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

Catalog Number	P4052
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the silverhawk with a 7f non-medtronic sheath and a spider fx 6mm, to treat a 150mm soft tissue lesion with 80-90% stenosis in the superficial and popliteal artery.Artery diameter 5mm.The device was inspected and prepped as per ifu with no issues noted.The vessel was not pre-dilated and no resistance was encountered.It was reported the tip of the silverhawk became damaged but did not completely detach.This occurred where the shaft meets the cutter.The physician opened a second silverhawk device.It was reported that the thumb switch was sticking and could not be pushed all the way forward.It is unknown if the cutter returned to the housing for removal of the device, but it was removed safely.The physician completed the procedure with the second device.No deformation was noted in the cutter when removed.No patient injury reported.
Additional Manufacturer Narrative
Additional information: email address product analysis: two silverhawk units were returned.The second unit had a cutter driver attached.No other ancillary devices were included.During visual inspection, biological debris was observed within the lumen of the housing assembly.The cutter was positioned 0.3cm distal the cutter window and the plunger was located approximately 0.6cm from the cutter window.A bend to the distal assembly housing was identified approximately 0.2cm from the cutter window.Functional testing was completed and the thumb switch was retracted with the cutter driver powered on.The cutter driver activated and the cutter driver retracted back into the cutter window as intended.The thumb switch was advanced, but stopped at 0.3cm distal the cutter window.The silverhawk was soaked in water for approximately 24 hours and flushed using a distal flush tool from the lab.An attempt was made to advance the thumb switch but the cutter stopped at approximately 0.3cm distal the cutter window.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8127926
• Report Number: 2183870-2018-00558
• Device Sequence Number: 13841144
• Product Code: MCW
• UDI-Device Identifier: 00821684074121
• UDI-Public: 00821684074121
• 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,Followup
• Report Date (Section B): 02/05/2019

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: 11/22/2018
• Device Catalogue Number: P4052
• Device Lot Number: A379918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78