MAUDE Adverse Event Report: COVIDIEN SILVERHAWK ATK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	P4055
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the silverhawk was returned inside saftpak biohazard packaging.Within the packaging included the silverhawk, detached cutter driver, green 0.014" guidewire, and 7 f sheath.No other ancillary devices were included.The guidewire was loaded inside the blue introducer sheath.Approximately 50cm of the guidewire was exposed outside of the distal ti p of the sheath.The guidewire distal the sheath showed a curve with an approximate 90 degree angle.At the area of the curve/bend, the green coating of the guidewire was stripped off.The stripped material appeared as though it was subjected to excessive friction.The distal rim of the introducer sheath showed a jagged surface to the rim.Approximately 111cm from the distal end of the guidewire it was observed the guidewire was coiled/curved.The silverhawk was inspected.The distal assembly showed a serpentine type bending throughout the coiled housing.Under microscope, it was identified the guidewire tubing exhibited zipper tearing.The proximal portion of the guidewire tubing was tore away from the distal assembly.The tubing material which appeared to tear off from the distal assembly was not included with the returned contents.The cutter was advanced within the housing of the distal assembly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use a silverhawk with a non-medtronic sheath and guidewire as per the ifu to treat a plaque lesion with little calcification and little tortuosity with 75% stenosis in the proximal left superficial femoral artery.The artery diameter and length were 6mm and 100mm respectively.No abnormalities were reported in relation to the patient¿s anatomy.The lesion was not pre-dilated.It was reported the tip detached during advancement.The wire lumen covering became detached during advancement of the catheter over iliac bifurcation, moderate resistance was felt.It was also reported that during advancement of the catheter over the iliac bifurcation resistance was felt, more pressure was applied but apparently the catheter became stuck and caused the sheath to prolapse into the aorta.As the physician was trying to remove the catheter from the sheath the wire lumen covering portion became completely detached and ended up being deposited in the left common femoral artery area.The lesion treated was the distal right sfa.The patient was reported to be stable during the procedure.An attempt was made to snare the piece of wire lumen covering, that became lodged in the left common femoral area.This was unsuccessful.The sheath was removed and exchanged for a new one.Access across the lesion was re-established and a new silverhawk lx-m was used to complete the procedure.The vessel was post-dilated.No further treatment is necessary.Patient is reported to be doing well.No patient injury was reported.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7662327
• Report Number: 9612164-2018-01619
• Device Sequence Number: 2501533
• Product Code: MCW
• UDI-Device Identifier: 00821684074145
• UDI-Public: 00821684074145
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2018
• Device Catalogue Number: P4055
• Device Lot Number: A334118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72