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

Catalog Number	P4034
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a silverhawk atherectomy device with a 6fr 45 cm sheath and 0.014 guidewire for the treatment of a 100-300mm moderately tortuous severely calcified lesion which exhibited 70-80% stenosis located in the left proximal mid popliteal artery <(>&<)> anterior tibial (at) artery of diameter 2-2.5mm.The ifu was followed and the vessel was pre-dilated.Guidewire was hydrated at prep.Severe resistance was felt during initial advancement.Device was unable to cross lesion.Device was advanced over bifurcation.Guidewire lumen was torn from distal tip.At was pre dilitated with a 2.5x 200 pta.A new catheter was able to advance post dilatation to treat lesion and complete the procedure.No damage was done to the vessel.No patient injury reported.
Additional Manufacturer Narrative
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: 6628996
• Report Number: 2183870-2017-00247
• Device Sequence Number: 757212
• 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,Followup
• Report Date (Section B): 05/11/2017

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: 05/23/2019
• Device Catalogue Number: P4034
• Device Lot Number: A282285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1