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

Catalog Number	P4034
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a silverhawk device for the treatment of a moderately tortuous moderately calcified lesion in mid tibial/popliteal trunk which exhibited cto (chronic total occlusion-100%).The device was inspected with no issues noted.Device prepped as per ifu without issue.The device is reported as being: jammed/will not close.This issue occurred during the first pass.It was possible to turn off the thumbswitch but not all of the way.The device stopped functioning while in use in the patient.Physician was using a silverhawk directional atherectomy device for the treatment of a moderately tortuous moderately calcified lesion in mid tibial/popliteal trunk which exhibited cto (chronic total occlusion).Device was prepped per ifu without issue.The device is reported as being: jammed/will not close.It was reported that this issue occurred during the first pass.It was possible to turn off the thumbswitch but not all the way.The device stopped functioning while in use in the patient.Device would not close all the way.The device was safely removed from the patient and there were no pieces of the cutter noticed to be missing.The procedure was successfully completed using a new device.No patient injury reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6709758
• Report Number: 2183870-2017-00301
• Device Sequence Number: 16198390
• Product Code: MCW
• UDI-Device Identifier: 00821684074084
• UDI-Public: 00821684074084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2019
• Device Catalogue Number: P4034
• Device Lot Number: A236585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1