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

Catalog Number	P4030
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2017
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
The physician was attempting to use a silverhawk directional atherectomy device to treat a 60mm moderately calcified lesion in the mid sfa.The artery was 6mm in diameter had little tortuosity.The vessel was not pre- or post-dilated.The silverhawk was prepped as per the ifu with no issues identified.The procedure used a 6 fr, 45cm non-medtronic sheath and a.014" non-medtronic guidewire.It was reported that at the beginning of the procedure, the cutter split the wire.The physician noticed the split, no damage was noted to the cutter.The cutter could be returned to the housing.The procedure was completed using an everflex stent.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk was inspected and observed guidewire loaded within the silverhawk was damaged.The silverhawk was inspected and verified the guidewire was loaded the distal and proximal guidewire tubing lumens.It was observed at the proximal end of the proximal guidewire tubing a tear was observed.The tear was located where the guidewire bend was observed.No other damages or anomalies to the silverhawk were noted.The green 0.014" guidewire was 300 cm in length.At the proximal end of the silverhawk guidewire tubing showed the wire bend back towards the distal tip.Approximately 6cm from the bend was a loop which showed the guidewire going back in the proximal direction.At the loop, the green coating of the wire was worn away.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7043320
• Report Number: 2183870-2017-00517
• Device Sequence Number: 11115447
• Product Code: MCW
• UDI-Device Identifier: 00821684074046
• UDI-Public: 00821684074046
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/15/2017

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: 05/03/2020
• Device Catalogue Number: P4030
• Device Lot Number: A455162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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