SilverHawkRecalls & reported problems across all models

We found 5 models of SilverHawk by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2018 and May 7, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SilverHawk problems

SilverHawk models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SilverHawk™ P4044

  Catheter, peripheral, atherectomy
  15 reports
• SilverHawk™ P4028

  Catheter, peripheral, atherectomy
  10 reports
• SilverHawk™ P4030

  Catheter, peripheral, atherectomy
  4 reports
• SilverHawk™ P4028

  Catheter, peripheral, atherectomy
  1 report
• SilverHawk™ P4044

  Catheter, peripheral, atherectomy
  1 report

Recent SilverHawk adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT AN ATHERECTOMY PROCEDURE USING THE ATHERECTOMY P4028 SILVERHAWK BTK WAS ATTEMPTED TO TREAT A CALCIFIED TARGET LESION IN THE MID SEGMENT OF THE RIGHT POSTERIOR TIBIAL ARTERY WITH SEVERE CALCIFICATION, 90% STENOSIS, 20 MM LESION LENGTH, 3 MM VESSEL DIAMETER, AND MINIMAL TORTUOSITY. THE VESSEL WAS PRE-DILATED USING A 2 X 20 NANOCROSS DILATION DEVICE, EMBOLIC PROTECTION WAS NOT USED, AND THE DEVICE WAS ADVANCED OVER A COMMAND 014 GUIDEWIRE WITH A FLEXOR CHECK-FLO 5 FR INTRODUCER SHEATH IN PLACE. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE GUIDEWIRE WAS REPORTED TO HAVE RIPPED THROUGH THE WHITE WIRE LUMEN ON THE NOSECONE, CAUSING THE WIRE TO WRAP AROUND THE NOSECONE AND MANGLE THE DEVICE. THE DEVICE WAS THEN PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED ALIVE WITH NO HEALTH CONSEQUENCES OR IMPACT, AND NO VESSEL DAMAGE, INJURY, OR INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109168 ↗
• MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SILVERHAWK DEVICE TIP DETACHED DURING CLEANING AFTER USE IN A PROCEDURE TO TREAT A PERIPHERAL ARTERY LESION IN THE ANTERIOR TIBIAL ARTERY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITHOUT COMPLICATIONS OR ISSUES. THE GUIDEWIRE LUMEN WAS NOT TORN/RIPPED. THE VESSEL WAS PRE-DILATED USING A NON-MEDTRONIC DEVICE.THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS OR ISSUES. NO PATIENT INJURY OR HEALTH CONSEQUENCES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160157 ↗
• MalfunctionJun 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  A SILVERHAWK ATHERECTOMY DEVICE WAS BEING USING FOR TREATMENT OF A 210MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE MID/DISTAL REGION OF THE RIGHT ANTERIOR TIBIAL ARTERY. THE ARTERY DIAMETER WAS 2-3MM WITH MODERATE CALCIFICATION AND TORTUOSITY. THE DEVICE WAS INSPECTED AND PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE CATHETER DID NOT EXPERIENCE DIFFICULTY LOCKING INTO THE CUTTER DRIVER. IT WAS REPORTED THE DEVICE WOULD NOT PACK. ONCE THE CTO WAS CROSSED IT WAS PRE-TREATED WITH 2.0-2.5X 210 TAPEREDNANOCROSS PTA. EXL WAS LOADED ONTO 0.014 NON-MEDTRONIC WIRE AND ADVANCED INTO ANTERIOR TIBIAL ARTERY. SEVERAL PASSES WERE MADE, AND PHYSICIAN NOTICED HE HAD DIFFICULTY TURNING INTO OFF POSITION. THE CUTTER BLADE WOULD NOT GO INTO THE HOUSING POSITION WHEN THE THUMB SWITCH WAS PUSHED INTO THE OFF POSITION BOTH WHEN THE DEVICE WAS IN THE PATIENT AND OUTSIDE THE PATIENT. THE CUTTER WAS OUTSIDE THE HOUSING DURING THE REMOVAL FROM THE PATIENT. THE SCRUB TECH PUSHED THE THUMBSWITCH FORWARD AND KEPT IT FORWARD DURING THE REMOVAL. THE BATTERY PACK WAS TURNED INTO OFF POSITION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND CLEANED PER IFU. NO DAMAGE TO THE PATIENT¿S VE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069681 ↗
• MalfunctionJan 27, 2023Difficult to Advance; Difficult to Advance

  A PHYSICIAN WAS ATTEMPTING TO USE A SLIVERHAWK ATHERECTOMY DEVICE FOR THE TREATMENT OF A PLAQUE LESION IN THE PROXIMAL REGION IN THE COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS ADVANCED OVER AN .014 WIRE WITH RESISTANCE THROUGH A 6FR DESTINATION CONTRALATERAL SHEATH. THE RESISTANCE BECAME MORE SEVERE WHILE ADVANCING ONCE THE DEVICE CAME OUT THE DISTAL END OF THE SHEATH, AND WIRE WRAP OCCURRED, CAUSING THE WIRE TO LOOP. ATTEMPTS WERE MADE BY THE PHYSICIAN TO CORRECT THE WIRE LOOP AND UNWRAP THE DEVICE AROUND THE WIRE, WITHOUT SUCCESS. ATTEMPTS WERE THEN MADE TO REMOVE THE DEVICE SAFELY WITHOUT LOSING WIRE AND SHEATH ACCESS. DUE TO THE SEVERITY OF WIRE WRAP AND WIRE BUCKLING, THE DEVICE, WIRE, AND SHEATH WERE ALL REMOVED FROM THE RIGHT CFA ACCESS SITE, WITHOUT ANY FOREIGN BODIES LEFT IN THE PATIENT. MANUAL PRESSURE WAS HELD SUCCESSFULLY TO THE ACCESS SITE UNTIL ADEQUATE HEMOSTASIS WAS ACHIEVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE BY ACCESSING THE LEFT CFA IN ANTEGRADE APPROACH. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252321 ↗
• MalfunctionMay 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN USED A SILVERHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 20MM PLAQUE LESION IN THE PATIENT'S PROXIMAL LEFT TIBIAL/POPLITEAL TRUNK OF DIAMETER 2.5MM. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 75% STENOSIS. THE DEVICE WAS PREPPED AS PER IFU. IT IS REPORTED THE NOSECONE DETACHED FROM CATHETER, THE DRIVESHAFT WAS STILL IN PLACE. DETACHMENT OCCURRED WHILE IN THE PATIENT, LIKELY WHILE ENTERING THE SHEATH. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE DETACHED COMPONENT WAS REMOVED. THE NOSECONE DID NOT DETACH COMPLETELY, EVERYTHING WAS REMOVED IN TANDEM WITH NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO VESSEL DAMAGE. A NEW CATHETER WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406333 ↗
• MalfunctionMar 30, 2022Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE SILVERHAWK BTK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL TO MID POSTERIOR TIBIAL ARTERY (PTA) TO ANTERIOR TIBIAL ARTERY (ATA) WITH 30% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A BREAK OCCURRED WHERE THE WIRE CAME OUT OF SIDE OF NOSE CONE. UNSURE IF THERE WAS A DAMAGE TO THE TECOTHANE. THE PLAQUE DID NOT EMBOLIZE DUE TO THE EVENT. THE TIP/NOSE CONE DID NOT DETACH FROM HINGE PIN. THERE WAS NO VESSEL DAMAGE DUE TO EVENT. THE LESION WAS TREATED WITH A BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13947873 ↗
• MalfunctionMar 2, 2022Peeled/Delaminated; Peeled/Delaminated

  PHYSICIAN WAS ATTEMPTING TO USE THE SILVERHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT PLAQUE IN THE MID LEFT TIBIAL/POPLITEAL TRUNK. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED WITH ISSUES NOTED. UPON REMOVAL OF THE CATHETER PHYSICIAN NOTICED NEAR THE PROXIMAL WIRE EXIT PORT AT THE RAPID EXCHANGE THE WHITE PORTION OF THE CATHETER WAS PEELING AND MISTOOK IT AS PLAQUE REMOVED FROM THE VESSEL AND SO PULLED ON IT. UPON FURTHER INSPECTION NOTICED IT WAS THE WHITE COATING ON THE SHAFT NEAR THE PROXIMAL WIRE EXIT PORT THAT WAS PEELING. IT IS UNKNOWN WHETHER IT IS THE PET LINER OR HYDROPHILIC COATING. THE DEVICE WAS NOT WIPED DOWN PRIOR OR IN BETWEEN USES. THE PEELING OCCURRED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. A NON MEDTRONIC 0.014¿ WIRE WAS USED. THERE WERE NO ISSUES WITH PATIENT AND NOTHING WAS LEFT IN PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653239 ↗
• MalfunctionSep 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE SILVERHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID TO DISTAL POSTERIOR TIBIAL ARTERY (PTA) WITH 40-70% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2-2.5MM AND 150MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUED NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. PACKAGING ISSUE OCCURRED. IT WAS REPORTED THAT AS PHYSICIAN WAS ATHERECTOMIES, THE THUMBSWITCH WOULD NOT GO INTO "OFF" POSITION. AS PHYSICIAN WAS USING THE ATHERECTOMY CATHETER, AFTER A FEW PASSES, THE SILVERHAWK WOULD NOT PACK/THUMBSWITCH WOULD NOT GO INTO "OFF" POSITION. THE DEVICE WAS REMOVED, FLUSHED AND CLEANED AS PER IFU BUT THE PROBLEM PERSISTENT WHEN IT WAS OUTSIDE OF THE PATIENT. PHYSICIAN TRIED RECONNECTING CATHETER TO CUTTER DRIVER, SUBMERGING NOSECONE IN SALINE AND TURNING IT ON, BUT THE PROBLEM PERSISTED. PHYSICIAN PUSHED THE THUMBSWITCH KEEPING FORT INTO OFF POSITION AND CUTTER DRIVER TURNED OFF, THE CUTTER WAS OUTSIDE THE HOUSING WHEN REMOVED FROM PATIENT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO INTERVENTION REQUIRED TO REMOVE DEVICE. A NEW CATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445384 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE SILVERHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE MID LEFT TIBIAL/POPLITEAL TRUNK WITH 100% CHRONIC TOTAL OCCLUSION(CTO).THE VESSEL WAS MODERATELY TORTUOUS AND WAS 2-3MM IN DIAMETER. THE LESION LENGTH WAS 10-12MM. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE GUIDEWIRE LUMEN BEGAN TO TEAR OR DISLODGE. THE TECOTHANE JACKET WAS TORN OPEN. NO GUIDEWIRE PROLAPSE NOTED. THE LUMEN DID NOT DISLODGE FROM SILVERHAWK. THE CUTTER WAS INSIDE THE HOUSING UNIT DURING REMOVAL FROM PATIENT. THE DEVICE WAS EASILY REMOVED FROM PATIENT. NO DETACHMENT WAS VISIBLE. NO INTERVENTION REQUIRED FOR REMOVAL. ARTERY WAS BALLOONED WITH NANOCROSS PTA BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369253 ↗
• MalfunctionJul 29, 2021Difficult to Remove; Device Damaged by Another Device; Material Deformation; Positioning Problem; Difficult to Remove; Device Damaged by Another Device; Material Deformation; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT POSTERIOR TIBIAL ARTERY. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. A MEDTRONIC NITREX GUIDEWIRE WAS USED. THE DEVICE WAS INSPECTED WITHOUT ISSUES NOTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PHYSICIAN NOTICED RESISTANCE WHEN TRYING TO REMOVE DEVICE FROM PATIENT. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DEVICE BECAUSE THE NOSE CONE DID NOT PASS THE CALCIFIED LESION. AS PHYSICIAN WAS TRYING TO REMOVE, IT WAS NOTICED THE WIRE LOOKED DISPLACED ANGIOGRAPHICALLY. WHEN THE DEVICE WAS TAKEN OUT IT WAS NOTICED THE GUIDEWIRE LUMEN IN THE NOSECONE CLOSEST TO THE CUTTER WINDOW WAS NOTED TO BE TORN. THE CUTTER WAS INSIDE THE HOUSING DURING DEVICE REMOVAL FROM PATIENT. NO DEFORMATION NOTED IN THE CUTTER. DAMAGE WAS NOTED TO THE TECOTHANE JACKET, WITH IT NOTED TO BE TORN. NO DETACHMENT OCCURRED. NO VESSEL DAMAGE NOTED. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO DAMAGE NOTED TO THE NITREX WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245078 ↗
• InjuryJun 8, 2021Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK ATHERECTOMY DEVICE WITH AN 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 95% STENOSIS. THE DEVICE WAS INSPECTED WITHOUT ISSUE. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE NON-MEDTRONIC GUIDEWIRE WRAPPED AROUND THE DISTAL NOSECONE OF THE CATHETER UPON ATTEMPTING TO REMOVE THE CATHETER. THE PHYSICIAN HAD TO PULL THE WIRE, ATHERECTOMY CATHETER, AND SHEATH OUT AT ONE TIME. IT CAUSED THE .014 NON-MEDTRONIC WIRE TO BREAK OFF ON THE DISTAL END. THE DISTAL TIP DETACHED FROM THE SILVERHAWK CATHETER. THE DISTAL TIP WAS TORN OFF. THE CUTTER WAS INSIDE THE HOUSING DURING REMOVAL FROM PATIENT. A SNARE WAS USED TO REMOVE THE DETACHED PIECE AND GUIDEWIRE. THE PHYSICIAN PULLED THE REMAINING .014 WIRE OUT OF THE BODY. NO VESSEL DAMAGE NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11956723 ↗
• MalfunctionJun 3, 2021Device Damaged by Another Device; Device Contamination with Chemical or Other Material; Device Damaged by Another Device; Device Contamination with Chemical or Other Material

  PHYSICIAN ATTEMPTED TO USE A SILVERHAWK BTK ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF AN 80MM SOFT TISSUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT POPLITEAL ARTERY. SLIGHT VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 4MM. IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED. IT IS REPORTED THAT AFTER RUNNING THE DEVICE AND PULLED OUT OF THE BODY, A BLACK STRING LIKE SUBSTANCE WAS ENCOUNTERED COMING OUT OF THE CUTTER WINDOW. THE OBSERVED MATERIAL APPEARED TO BE FIBROUS. UNCLEAR IF THIS WAS PART OF THE DEVICE. THE DEVICE WAS NOT WIPED DOWN BETWEEN INSERTIONS. THE CUTTER WAS INSIDE HOUSING WHEN REMOVED. WHEN REMOVED FROM PATIENTS, ALL PARTS OF DEVICE WERE ACCOUNTED FOR. THE DEVICE WAS REMOVED SAFELY. A REPLACEMENT HAWK ONE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929667 ↗
• MalfunctionOct 23, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A SILVER-HAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 30MM SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL AND MID PERONEAL ARTERY. SLIGHT VESSEL TORTUOSITY IS REPORTED. LESION EXHIBITED 60% STENOSIS. ARTERY DIAMETER REPORTED AS 3MM. IFU WAS FOLLOWED, AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. A BREAK IS REPORTED. IT IS REPORTED THE NOSE-CONE SEPARATED. THE ISSUE OCCURRED INSIDE THE PATIENT. ALL COMPONENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT WITH NO INTERVENTION REQUIRED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH THE CUTTER INSIDE THE HOUSING. THERE WAS NO VESSEL DAMAGE NOTED. THE PROCEDURE WAS COMPLETED ALREADY PRIOR TO THE SILVER-HAWK NOSE-CONE DETACHMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10725239 ↗
• MalfunctionAug 24, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A SILVERHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. MODERATE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. THE DEVICE WAS INSPECTED. NO ISSUES WERE NOTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT POST ATHERECTOMY WHEN REMOVING HE DEVICE FROM THE PATIENT, THE PHYSICIAN FELT RESISTANCE. UNDER FLUOROSCOPY IT WAS OBSERVED THE WIRE WRAPPED AND PROLAPSED AROUND THE ATHERECTOMY DEVICE. THE PHYSICIAN COULD NOT UNWRAP THE WIRE AND DECIDED PULLED THE DEVICE RESULTING IN THE WIRE AND DEVICE COMING OUT IN PIECES. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO VESSEL INJURY AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441406 ↗
• MalfunctionJul 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A SILVERHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO THE A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL POPLITEAL ARTERY, TIBIAL/ POPLITEAL TRUNK AND ANTERIOR TIBIAL ARTERY. THE VESSEL IS LITTLE TORTUOUS. THE DEVICE WAS INSPECTED PER IFU WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED. A BREAK OCCURRED. IT WAS REPORTED THAT PHYSICIAN REALIZED DEVICE WAS BROKEN AFTER LOADING OVER THE WIRE AND THROUGH THE SHEATH. IT WAS NOT BROKEN WHEN INITIALLY LOADING ONTO THE WIRE. DEVICE WAS WORKING FINE, DEVICE WAS REMOVED TO BE CLEANED, THEN ONCE CLEANED, LOADED IT BACK ON THE WIRE. ONCE INSIDE THE BODY, PHYSICIAN REALIZED UNDER X-RAY THAT THE DEVICE WAS DISCONNECTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288135 ↗

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