Diamondback Peripheral DBP-125MICRO145 (UDI 10852528005190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10852528005190), received between Sep 17, 2015 and Dec 22, 2016 — classified as 9 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A TYPE D DISSECTION OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN USED A 5FR INTRODUCER SHEATH AND A V18 CROSSING GUIDE WIRE TO ACCESS THE LESION. THE V18 GUIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED ONE RUN AT LOW SPEED AND ONE RUN AT MEDIUM SPEED IN THE AT ARTERY. POST-ATHERECTOMY ANGIOGRAPHY REVEALED A TYPE D DISSECTION IN THE AT ARTERY. A 2.5MM X 60MM BALLOON WAS INFLATED ACROSS THE DISSECTION FOR THREE MINUTES AND RESOLVED IT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: Vascular Dissection

  MAUDE report 6198512 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND A TYPE A DISSECTION OCCURRED. THE EVENTS WERE IDENTIFIED BY A THIRD PARTY VENDOR, CORE LAB. CORE LAB REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A CSI CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. THE PHYSICIAN USED A 6FR INTRODUCER SHEATH AND A STIFF-ANGLED GLIDEWIRE GUIDE WIRE TO ACCESS THE LESION. THE GLIDEWIRE GUIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING THE OAD AND FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. AT THIS POINT, THE PHYSICIAN TREATED ADDITIONAL FOCAL LESIONS VIA DIFFERENT ATHERECTOMY MODALITIES. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED A PERFORATION AND A TYPE A DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE CORE LAB ANGIOGRAM EVALUATION WAS REVIEWED BY CSI FOR POTENTIAL ADVERSE EVENTS ON 29 APRIL 2016.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 5684828 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND A TYPE A DISSECTION OCCURRED. THE EVENTS WERE IDENTIFIED BY A THIRD PARTY VENDOR, CORE LAB. CORE LAB REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A CSI CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE PHYSICIAN THEN FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED A PERFORATION AND A TYPE A DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE CORE LAB ANGIOGRAM EVALUATION WAS REVIEWED BY CSI FOR POTENTIAL ADVERSE EVENTS ON 29 APRIL 2016.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 5684818 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A TYPE C DISSECTION OCCURRED. THE EVENT WAS IDENTIFIED BY A THIRD PARTY VENDOR, CORE LAB. CORE LAB REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A CSI CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN USED A 6FR INTRODUCER SHEATH, 0.018" QUICKCROSS GUIDE CATHETER AND A MIRACLEBROS GUIDE WIRE TO ACCESS THE LESION. THE MIRACLEBROS GUIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING THE OAD AND FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED A TYPE C DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE CORE LAB ANGIOGRAM EVALUATION WAS REVIEWED BY CSI FOR POTENTIAL ADVERSE EVENTS ON 29 APRIL 2016.

  Patient problems: Vascular Dissection

  MAUDE report 5684811 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND A TYPE A DISSECTION OCCURRED. THE EVENTS WERE IDENTIFIED BY A THIRD PARTY VENDOR, (B)(4). (B)(4) REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A (B)(6) CLINICAL TRIAL. THE TARGET LESION ORIGINATED IN THE ANTERIOR TIBIAL (AT) ARTERY AND EXTENDED INTO THE DORSALIS PEDIS (DP) ARTERY. THE PHYSICIAN USED A 7FR/40CM INTRODUCER SHEATH AND A TRAILBLAZER GUIDE WIRE TO ACCESS THE LESION. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING THE OAD AND FOLLOWED-UP ATHERECTOMY WITH BALLOON ANGIOPLASTY. AT THIS POINT, THE PHYSICIAN TREATED ADDITIONAL FOCAL LESIONS VIA DIFFERENT ATHERECTOMY MODALITIES. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY (B)(4) IDENTIFIED A PERFORATION AND A TYPE A DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE (B)(4) ANGIOGRAM EVALUATION WAS REVIEWED BY (B)(4) FOR POTENTIAL ADVERSE EVENTS ON (B)(6) 2016.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 5684793 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND TYPE B DISSECTION OCCURRED. THE EVENTS WERE IDENTIFIED BY A THIRD PARTY VENDOR, CORE LAB. CORE LAB REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A CSI CLINICAL TRIAL. THE TARGET LESION ORIGINATED IN THE TIBIO-PERONEAL TRUNK (TPT) AND EXTENDED INTO THE DORSALIS PEDIS (DP) ARTERY. THE PHYSICIAN ADVANCED A CSI VIPERWIRE GUIDE WIRE ACROSS THE LESION AND LOADED A CSI ORBITAL ATHERECTOMY DEVICE (OAD) ONTO IT. THE PHYSICIAN TREATED THE LESION WITH THE OAD AND FOLLOWED-UP ATHERECTOMY WITH TWO BALLOON ANGIOPLASTY INFLATIONS. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED A PERFORATION AND A TYPE B DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE CORE LAB ANGIOGRAM EVALUATION WAS REVIEWED BY CSI FOR POTENTIAL ADVERSE EVENTS ON 29 APRIL 2016.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 5684775 ↗
• InjuryMay 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A TYPE C DISSECTION OCCURRED. THE EVENT WAS IDENTIFIED BY A THIRD PARTY VENDOR, CORE LAB. CORE LAB REVIEWED ALL PROCEDURAL ANGIOGRAMS AS PART OF A CSI CLINICAL TRIAL. THE TARGET LESION ORIGINATED IN THE DISTAL POPLITEAL ARTERY AND EXTENDED INTO THE PERONEAL ARTERY. THE PHYSICIAN USED MULTIPLE GUIDE WIRES AND GUIDE CATHETERS, AS WELL AS MULTIPLE BALLOON INFLATIONS TO ACCESS AND CROSS THE LESION. A CSI VIPERWIRE GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED MULTIPLE RUNS AT LOW, MEDIUM AND AT HIGH SPEED. POST-ATHERECTOMY ANGIOGRAPHY DID NOT REVEAL ANY COMPLICATIONS. THE PHYSICIAN REMOVED THE CSI OAD AND GUIDE WIRE AND RE-WIRED THE LESION WITH A MAILMAN GUIDE WIRE. ATHERECTOMY WAS FOLLOWED-UP WITH BALLOON ANGIOPLASTY AND STENT DEPLOYMENT. POST-PROCEDURE ANGIOGRAPHY DID NOT REVEAL ANY COMPLICATIONS AND THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. FOLLOW-UP REVIEW BY CORE LAB IDENTIFIED A TYPE D DISSECTION; HOWEVER, NO COMPLICATIONS WERE NOTED BY THE TREATING PHYSICIAN DURING THE PROCEDURE. THE CORE LAB ANGIOGRAM EVA

  Patient problems: Vascular Dissection

  MAUDE report 5684773 ↗
• InjuryOct 15, 2015Entrapment of Device; Retraction Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE, A CSI ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED. THE TARGET LESION WAS 90% STENOTIC AND WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL (AT) ARTERY. DURING THE FIRST RUN AT LOW SPEED, THE OAD GOT STUCK IN THE LESION. THE CONTROL KNOB ON THE OAD WAS UNABLE TO BE ADVANCED OR RETRACTED. THE PHYSICIAN ATTEMPTED TO DISLODGE THE DEVICE BY INFLATING A BALLOON NEXT TO THE CROWN, BUT WAS UNSUCCESSFUL. THE DRIVESHAFT SALINE SHEATH AND GUIDEWIRE WERE ALSO CUT IN AN ATTEMPT TO MANUALLY ROTATE AND REMOVE THE OAD, BUT THE ATTEMPT WAS UNSUCCESSFUL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A SURGICAL CUT-DOWN AND REMOVAL OF THE DEVICE. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5152669 ↗
• InjurySep 17, 2015Material Fragmentation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PORTION OF A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LEFT IN THE PATIENT. THERE WERE MULTIPLE TARGET LESIONS IN THE PERONEAL ARTERY THAT SPANNED 5CM. THE PHYSICIAN USED A 6FR/45CM DESTINATION INTRODUCER SHEATH AND A 0.018" CXI CROSSING WIRE TO ACCESS THE LESION. THE CXI WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDEWIRE AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN COMPLETED ONE RUN AT LOW SPEED FOR 40 SECONDS. DURING AN ATTEMPT TO REMOVE THE DEVICE, THE PHYSICIAN DISCOVERED THAT THE OAD WAS STUCK IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO PULL THE GUIDEWIRE THROUGH THE DEVICE, BUT IT BECAME STUCK IN THE DEVICE. THE PHYSICIAN WAS THEN ABLE TO REMOVE THE OAD AND GUIDEWIRE AS A UNIT FROM THE PATIENT. HOWEVER, A PORTION OF THE DRIVESHAFT HAD FRACTURED AND WAS LEFT IN THE PATIENT. ADDITIONALLY, THROMBUS WAS NOTED IN THE PERONEAL ARTERY AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A FEMORAL-TO-TIBIAL BYPASS. THREE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5085265 ↗