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

Catalog Number	P4044
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two images were received for evaluation.The first image is a photograph of a cine showing the silverhawk in the patient.The distal assembly coil section of the silverhawk exhibits stretching of the coil and kinking.The second image is a photograph of the silverhawk.A guidewire has torn free of the guidewire lumen in the distal half of the coil section of the distal assembly and the distal assembly exhibits a kink.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a silverhawk device for treatment of a 90% stenosed plaque 40mm lesion in the patients proximal tibial/popliteal trunk.Slight tortuosity and calcification were reported.Ifu was followed and the device was prepped without issue.The procedure used a 7fr non-mdt sheath and a 0.014" non-mdt guidewire.It is reported the wire became wrapped around the device and caused the wire to break in half.The distal tip of the device also broke in half.This was noticed when withdrawing the device after performing atherectomy.The distal tip of the device would not fit through the sheath.The sheath, wire, and device had to be removed together.No component embolisation occurred.The incident occurred after atherectomy had been performed and the physician stopped the procedure after the incident.The patient had a minor hematoma related to removing the sheath while still heparinized.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7581546
• Report Number: 2183870-2018-00322
• Device Sequence Number: 11143921
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/08/2018

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: 09/07/2019
• Device Catalogue Number: P4044
• Device Lot Number: A520101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/08/2018
• 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: Other
• Patient Age: 70 YR
• Patient Weight: 132