Diamondback Peripheral DBP-125SOLID145 (REF 7-10012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10852528005244), received between Nov 20, 2017 and Dec 7, 2020 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2020Device Remains Activated; Device Remains Activated

  SEVERAL TREATMENTS WERE ADMINISTERED WITH THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). ANOTHER TREATMENT WAS ATTEMPTED, BUT THE OAD DID NOT SPIN. THE BRAKE WAS ADJUSTED, THE CONTROL KNOB WAS MANIPULATED, AND THE OAD THEN FUNCTIONED AS INTENDED. HOWEVER, WHEN THE USER ATTEMPTED TO TURN OFF THE OAD, THE ON/OFF BUTTON HAD TO BE PRESSED MULTIPLE TIMES BEFORE TREATMENT CEASED. THE PROCEDURE WAS COMPLETED WITH A GOOD RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960496 ↗
• InjuryNov 10, 2020Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A LESION IN THE ANTERIOR TIBIAL ARTERY (AT). THE PATIENT WAS SCHEDULED FOR AMPUTATION, BUT OA TREATMENT WAS SELECTED AS A FINAL EFFORT TO AVOID AMPUTATION. THE PHYSICIAN WAS AWARE THAT ATHERECTOMY COULD BE CHALLENGING. THE OAD BECAME STUCK IN THE VESSEL DURING USE. THE WIRE WAS REMOVED FROM THE OAD. THE DRIVESHAFT OF THE OAD WAS CUT NEAR THE STRAIN RELIEF. A NON-CSI WIRE WAS ADVANCED INTO THE AT IN AN ATTEMPT TO FREE THE CROWN. THE DRIVESHAFT OF THE OAD FRACTURED, AND THE FRAGMENT REMAINED IN VIVO. THE PATIENT WAS STABLE AND UNDERWENT THE PREVIOUSLY PLANNED AMPUTATION.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10819850 ↗
• InjuryApr 27, 2020Entrapment of Device; Entrapment of Device

  DURING TREATMENT, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE PERONEAL. THE OAD WAS STOPPED, RE-STARTED AND GENTLY PULLED BACK UNTIL IT DISLODGED. THE OAD WAS THEN ABLE TO BE REMOVED FROM THE PATIENT. A PERFORATION WITH EXTRAVASATION OCCURRED, AND BALLOON INFLATION WAS PERFORMED. THE VESSEL DID NOT REMAIN PATENT FOLLOWING REMOVAL OF THE BALLOON, HOWEVER ANOTHER VESSEL WAS OPENED TO SUPPLY IN-LINE FLOW TO THE FOOT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels; Vascular System (Circulation), Impaired; Vessel Or Plaque, Device Embedded In

  MAUDE report 10001006 ↗
• InjuryDec 16, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION IN THE ANTERIOR TIBIAL ARTERY (AT). THERE WAS PRE-EXISTING NO FLOW TO THE FOOT DUE TO THE OCCLUSION. THE LESION WAS PRE-DILATED WITH A BALLOON. DURING TREATMENT, THE DEVICE STOPPED SPINNING: THE OAD WAS STUCK ON THE WIRE AND WAS STUCK IN THE VESSEL. ALTERNATIVE ACCESS WAS GAINED IN THE DORSALIS PEDIS ARTERY, AND THE CROWN WAS LOOSENED VIA THAT APPROACH. A BALLOON WAS INFLATED NEAR THE CROWN, AND THE DEVICE WAS REMOVED. DURING REMOVAL, THE OAD CROWN BECAME STUCK AGAIN NEAR THE AT BEND, AND THE CROWN AND DISTAL DRIVESHAFT FRACTURED AND WERE REMOVED. THE EVENT CAUSED A DELAY THAT WAS GREATER THAN 30 MINUTES.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9473500 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON ALL SPEEDS DURING TREATMENT TO THE PROXIMAL SIDE OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO ISSUES OBSERVED. THE OAD WAS ADVANCED TO THE DISTAL SIDE OF THE SFA AND THE PATIENT PRESENTED WITH HYPOTENSION AND BRADYCARDIA. ADMINISTRATION OF PHARMACOLOGICAL THERAPY WAS PERFORMED TO STABILIZE THE PATIENT, AND THE TREATMENT WAS CONTINUED. THE OAD SOUNDED AS THOUGH IT WERE LOSING SPEED AND THE LOW SPEED BUTTON BEGAN BLINKING. TROUBLESHOOTING ATTEMPTS TO POWER THE OAD ON AND OFF WERE UNSUCCESSFUL, AND A SECOND OAD WAS OPENED TO COMPLETE THE PROCEDURE. THE REPORTED ISSUES WITH THE OAD OCCURRED AFTER THE REPORTED PATIENT ADVERSE EVENT AND THERE IS NO INDICATION THAT THE TWO EVENTS ARE RELATED. THE PATIENT WAS REPORTEDLY WELL. PER THE OPINION OF THE PHYSICIAN, IT WAS UNCLEAR WHY THE PATIENT BECAME SYMPTOMATIC DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED HYPOTENSION IN PREVIOUS PROCEDURES.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 9383875 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TARGET LESION WAS A HIGHLY CALCIFIED, CHRONIC TOTAL OCCLUSION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THROMBUS WAS OBSERVED TO BE PRESENT PRIOR TO THE PROCEDURE, AND WAS REMOVED WITH A THROMBECTOMY DEVICE. FOLLOWING REMOVAL OF THE THROMBUS, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED AND USED TO TREAT THE LESION. THE OAD WAS THEN REMOVED AND BALLOON ANGIOPLASTY WAS PERFORMED, DURING WHICH A PERFORATION OCCURRED. BALLOON ANGIOPLASTY WAS CONTINUED, AND THE PERFORATION SEALED INDEPENDENTLY WITHOUT USE OF A STENT. THE CAUSE OF THE PERFORATION WAS UNKNOWN AS IMAGING WAS NOT PERFORMED BETWEEN TREATMENTS. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 9161381 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A THROMBUS WHICH RESULTED IN NO FLOW WAS OBSERVED ON IMAGING IN THE TIBIOPERONEAL TRUNK (TPT) FOLLOWING THREE TREATMENTS ON LOW SPEED FOR 20 SECONDS EACH WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN THE PROXIMAL TO DISTAL POPLITEAL ARTERY AND THE POSTERIOR TIBIAL ARTERY. A THROMBECTOMY DEVICE WAS USED TO REMOVE THE THROMBUS AND WAS SUCCESSFUL IN RESTORING FLOW TO THE TPT. WHEN IMAGING WAS PERFORMED AGAIN, THROMBUS WAS OBSERVED IN THE ANTERIOR TIBIAL (AT) ARTERY, AND FLOW WAS SLUGGISH. FOLLOWING TREATMENT OF THE AT WITH THE THROMBECTOMY DEVICE, THE AT WAS OPEN WITH MODERATELY BRISK FLOW. PRIOR TO THE OBSERVATION OF THROMBUS FOLLOWING ORBITAL ATHERECTOMY, BOTH THE TPT AND THE AT WERE OPEN AND FLOW WAS NORMAL. THE PATIENT HAD BEEN APPROPRIATELY HEPARINIZED DURING PREPARATION FOR THE PROCEDURE WITH 6000 UNITS.

  Patient problems: Thrombus; Vascular System (Circulation), Impaired

  MAUDE report 8798274 ↗
• MalfunctionJul 12, 2019Failure to Advance; Unexpected Shutdown; Failure to Advance; Unexpected Shutdown

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED IN AN ATTEMPT TO TREAT A TARGET LESION IN THE MID-ANTERIOR TIBIAL ARTERY. THE SEVERELY CALCIFIED, 100% STENOSED LESION WAS 10 CM IN LENGTH AND LOCATED IN A MINIMALLY TORTUOUS SECTION OF THE ARTERY. THE LESION WAS INITIALLY WIRED WITH A NON-CSI GUIDE WIRE, AND IT APPEARED THAT DURING THE INITIAL ATTEMPT TO PLACE THE WIRE, THE WIRE WAS SUBINTIMAL. THE WIRE WAS THEN PLACED IN THE TRUE LUMEN AND EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE. THE LESION WAS ENGAGED WITH THE OAD, AND THEN STOPPED SPINNING WHEN IT CAME INTO CONTACT WITH A PIECE OF CALCIUM IN THE LESION. ATTEMPTS TO CROSS THE LESION WITH THE OAD WERE MADE ON BOTH LOW AND HIGH SPEEDS, BUT ALL ATTEMPTS WERE UNSUCCESSFUL, AND THE DEVICE STOPPED SPINNING AT THE SAME SPOT EACH TIME. IT WAS NOTED THAT THE CORRECT OAD CROWN SIZE HAD BEEN CHOSEN AND USED FOR THE PROCEDURE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO CROSS THE LESION WITH A BALLOON, RESULTING IN THE PROCEDURE BEING ABORTED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784525 ↗
• MalfunctionMar 6, 2019Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO CSI VIA MEDWATCH MW5083148 THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE, A DEVICE MALFUNCTION OCCURRED. THE TARGET LESION WAS LOCATED BELOW THE KNEE IN A TIBIAL ARTERY, AND WAS TREATED WITH 2-3 PASSES OF THE OAD. FOLLOWING THE TREATMENT, IT WAS NOTED THAT FLUID WAS LEAKING FROM THE DEVICE TUBING BELOW THE CONNECTION TO THE SALINE PUMP. CONCERN WAS EXPRESSED BY THE STAFF THAT NO FLUID HAD BEEN FLOWING THROUGH THE DEVICE DURING TREATMENT. NON-CSI SALINE TUBING WAS USED IN AN ATTEMPT TO CORRECT THE LEAK, ALTHOUGH IT IS UNCLEAR IF THIS WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS REQUESTED FOR THIS EVENT, HOWEVER THE SITE DECLINED TO PROVIDE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396461 ↗
• MalfunctionDec 11, 2018Entrapment of Device; Entrapment of Device

  DURING A PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) THE MOTOR REPORTEDLY DID NOT FULLY ENGAGE WHEN THE PHYSICIAN ATTEMPTED TO INCREASE THE SPEED TO MEDIUM IN A 100% STENOSED LESION IN A 3 MM AREA OF THE MID TO DISTAL POST TIBIAL ARTERY. THE DEVICE WAS TURNED TO LOW AND BACK TO MEDIUM, BUT THE ISSUE RECURRED. THE DEVICE WAS STUCK ON THE WIRE AND BOTH THE DEVICE AND WIRE WERE REMOVED FROM THE PATIENT. WHEN THE PHYSICIAN ATTEMPTED TO REWIRE THE VESSEL USING A NON-CSI GUIDE WIRE, A PERFORATION IN A COLLATERAL VESSEL OCCURRED. A BALLOON WAS USED, THE PHYSICIAN WAS ABLE TO INTRODUCE BLOOD FLOW TO THE FOOT THROUGH THE POST TIBIAL ARTERY, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 8151538 ↗
• MalfunctionDec 3, 2018Infusion or Flow Problem; Noise, Audible; Unexpected Shutdown; Infusion or Flow Problem; Noise, Audible; Unexpected Shutdown

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE ISSUE OCCURRED. THE TARGET LESION WAS 75% STENOSED AND LOCATED IN THE ANTERIOR TIBIAL ARTERY. DURING TREATMENT OF THE LESION WITH THE OAD, THE DEVICE EMITTED A STRANGE NOISE AND SEEMED TO STOP SPINNING. THE DEVICE WAS TURNED OFF, MOVED BACKWARD, AND RESTARTED, HOWEVER THE SAME ISSUE OCCURRED. FLUID WAS NOTED TO BE LEAKING FROM THE FRONT OF THE DEVICE, AND BLOOD WAS NOTED TO FLOW BACK THROUGH THE CATHETER. THE NOSE CONE OF THE DEVICE WAS NOTED TO BE LOOSE. WHEN THE DEVICE WAS REMOVED, IT WAS FOUND TO BE STUCK ON THE GUIDE WIRE. THE OAD AND WIRE WERE REMOVED TOGETHER, THE LESION WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THE PATIENT WAS DISCHARGED THE DAY FOLLOWING THE PROCEDURE AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125744 ↗
• MalfunctionNov 9, 2018Difficult to Advance; Difficult to Advance

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD) A DEVICE MALFUNCTION OCCURRED LEADING TO A PROCEDURAL DELAY. UPON INSERTION, THE PERIPHERAL DEVICE WAS DIFFICULT ADVANCE OVER THE GUIDE WIRE AND REQUIRED ADDITIONAL TIME TO REACH THE LESION. THE FIRST TARGET LESION WAS 100% STENOSED AND WAS TREATED WITH THE OAD. FOLLOWING TREATMENT, THE DEVICE WAS UNABLE TO ADVANCE TO THE NEXT LESION AND WAS DIFFICULT TO REMOVE FROM THE PATIENT, LEADING TO A PROCEDURAL DELAY. THE DEVICE AND WIRE WERE REMOVED TOGETHER AND THE LESION WAS RE-WIRED AND THE OAD REPLACED TO COMPLETE THE PROCEDURE WITH ADDITIONAL ATHERECTOMY AND BALLOON ANGIOPLASTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054716 ↗
• InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN EMBOLISM OCCURRED DURING AN ATHERECTOMY PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE. THE PATIENT UNDERWENT AN HOUR OF ADDITIONAL PROCEDURE TIME IN ORDER TO TREAT THE REPORTED EMBOLISM. THE PROCEDURE WAS COMPLETED FOLLOWING THE DELAY. (B)(4).

  Patient problems: Embolism

  MAUDE report 7878708 ↗
• InjuryJul 3, 2018Device Stops Intermittently; Device Stops Intermittently

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), SLOW FLOW AND THROMBUS OCCURRED. THE TARGET LESION WAS 80% STENOSED AND LOCATED IN THE ANTERIOR TIBIAL ARTERY. DURING ATHERECTOMY TREATMENT, THE OAD STOPPED FUNCTIONING MULTIPLE TIMES. FOLLOWING ATHERECTOMY TREATMENT, THROMBUS WAS NOTED WHICH WAS CAUSING SLOW FLOW. THE THROMBUS WAS EXTRACTED USING AN ASPIRATION CATHETER AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT TWO DAYS FOLLOWING THE PROCEDURE THE PATIENT UNDERWENT AN ABOVE KNEE AMPUTATION DUE TO COMPARTMENT SYNDROME CAUSED BY A PRIOR PROCEDURE WITH A NON-CSI DEVICE.

  Patient problems: No Code Available; Thrombus

  MAUDE report 7660069 ↗
• InjuryJun 8, 2018Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK IN THE LESION. THE TARGET LESION WAS A TOTAL OCCLUSION AND WAS LOCATED IN THE PROXIMAL POSTERIOR TIBIAL ARTERY. DURING ATHERECTOMY TREATMENT, THE OAD BECAME STUCK IN THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS FOUND TO BE STUCK ON THE INTRODUCER SHEATH AND THE DEVICES WERE REMOVED TOGETHER. A LARGE AMOUNT OF TISSUE WAS NOTED TO BE WRAPPED AROUND THE CROWN. THE LESION WAS RE-WIRED AND ANOTHER OAD WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS REPORTED. UPON ANALYSIS OF THE REPORTED DEVICE, IT WAS FOUND THAT A PREVIOUSLY PLACED STENT WAS PRESENT ON THE CROWN OF THE OAD.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7582462 ↗
• InjuryJun 7, 2018Noise, Audible; Noise, Audible

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY AND WAS TREATED WITH THE OAD USING TWO PASSES ON LOW SPEED AND ONE PASS ON MEDIUM SPEED. FOLLOWING THE THIRD PASS, THE DEVICE BEGAN TO MAKE AN ABNORMAL NOISE AND WAS REMOVED. TISSUE WRAP WAS NOTED ON THE CROWN OF THE OAD, AND IMAGING SHOWED A FLOW LIMITING DISSECTION AND THROMBUS. BALLOON ANGIOPLASTY WAS PERFORMED FOR FOUR MINUTES TO RESOLVE THE DISSECTION AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Thrombus; Vascular Dissection

  MAUDE report 7579765 ↗
• InjuryMay 17, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. LESIONS IN THREE SEGMENTS OF THE ANTERIOR TIBIAL ARTERY WERE TREATED USING MULTIPLE PASSES WITH THE OAD ON LOW, MEDIUM AND HIGH SPEEDS. WHEN THE OAD WAS ACTIVATED AGAIN FOLLOWING A REST PERIOD, THE DEVICE STALLED AND BECAME STUCK ON THE GUIDE WIRE. THE OAD AND WIRE WERE REMOVED TOGETHER AND WHEN IMAGING WAS PERFORMED A DISSECTION WAS NOTED. BYPASS SURGERY WAS PERFORMED TO RESOLVE THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 7522852 ↗
• MalfunctionMay 15, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK ON THE GUIDE WIRE LEADING TO A PROCEDURAL DELAY. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN TORTUOUS ANATOMY IN THE ANTERIOR TIBIAL ARTERY. FOLLOWING TREATMENT WITH THE OAD, THE DEVICE BECAME STUCK ON THE GUIDE WIRE. THE DEVICE AND WIRE WERE REMOVED TOGETHER, LEADING TO A 45 MINUTE PROCEDURAL DELAY WHILE THE LESION WAS RE-WIRED. FOLLOWING INSERTION OF ANOTHER GUIDE WIRE, THE PROCEDURE WAS COMPLETED WITH ADDITIONAL ATHERECTOMY TREATMENT AND BALLOON ANGIOPLASTY. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7514506 ↗
• InjuryMay 4, 2018Entrapment of Device; Unintended System Motion; Entrapment of Device; Unintended System Motion

  DURING AN ATHERECTOMY PROCEDURE USING A CSI PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESION WAS IN THE TIBIAL-PERONEAL TRUNK (TPT) ARTERY. THE CROWN OF THE DEVICE WAS NOTED TO JUMP BACK AT THE COMPLETION OF THE PASSES THROUGH THE LESION. UPON REMOVAL OF THE DEVICE, IT WAS NOTED TO BE STUCK ON THE GUIDE WIRE. THE DEVICE AND THE WIRE WERE REMOVED TOGETHER AND A DISSECTION WAS NOTED TO HAVE OCCURRED. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF A STENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE PROCEDURE AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7487836 ↗
• MalfunctionMay 1, 2018Unintended System Motion; Unintended System Motion

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE MALFUNCTION OCCURRED LEADING TO A PROCEDURAL DELAY. THE TARGET LESIONS WERE LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND ANTERIOR TIBIAL ARTERY (AT). WHEN THE OAD WAS POWERED ON TO BEGIN TREATMENT, THE CROWN WAS NOTED TO MOVE APPROXIMATELY 3 CM OUTSIDE OF OPERATOR CONTROL. THE DEVICE WAS REPOSITIONED, HOWEVER WHEN IT WAS POWERED ON THE CROWN JUMPED AGAIN. THE LESION IN THE SFA WAS TREATED USING ONE PASS WITH THE OAD, HOWEVER THE UNCONTROLLED MOVEMENT OCCURRED TWO MORE TIMES. THE OAD WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. IT WAS REPORTED THAT THE DEVICE ISSUE LED TO A 30 MINUTE PROCEDURAL DELAY. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7477974 ↗
• InjuryApr 2, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK IN THE PATIENT AND REQUIRED SURGERY TO REMOVE. THE TARGET LESION WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL ARTERY. DURING TREATMENT OF THE LESION WITH THE OAD, THE DEVICE BECAME STUCK IN THE PATIENT. SURGERY WAS PERFORMED TO REMOVE THE DEVICE AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7390029 ↗
• InjuryNov 20, 2017Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION OCCURRED AND A PORTION OF THE WIRE BECAME DETACHED. WHEN THE CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO TREAT A HEAVILY CALCIFIED LESION, THE CROWN BECAME STUCK IN THE LATERAL PLANTAR ARTERY AND THE TIP OF THE GUIDEWIRE BECAME DETACHED. A NON-CSI CATHETER AND GUIDEWIRE, AND BALLOON WERE INSERTED, HOWEVER THE BALLOON WAS UNABLE TO BE ADVANCED AROUND THE HEEL BEND. IMAGING WAS PERFORMED AND A PERFORATION WAS NOTED. SURGERY WAS COMPLETED TO REMOVE THE OAD AND THE GUIDEWIRE TIP, AND A BYPASS WAS PERFORMED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7045511 ↗