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

Catalog Number	P4030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
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
Physician used a silverhawk device during treatment of a 60mm moderately calcified lesion with 95% stenosis in the mid right popliteal artery of diameter 8mm.The vessel was described as having little tortuosity.The device was prepped as per ifu without issue.It is reported that during removal, the wire port of the silverhawk peeled away from the catheter.The wire was stuck in the wire port and the catheter and wire had to be removed together.No patient injury reported.Patient has a history of hypertension and peripheral vascular disease.
Additional Manufacturer Narrative
The silverhawk was returned for analysis.No ancillary devices were included.A visual inspection was completed and a 3cm zipper tear to the torque shaft guidewire tubing was observed.The tear originated at the proximal end of the torque shaft guidewire tubing.The segment of guidewire tubing within the white torque shaft layer was protruding out from the catheter.Buckling was observed at the area where the tearing stopped.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: 7446068
• Report Number: 2183870-2018-00236
• Device Sequence Number: 2195952
• Product Code: MCW
• UDI-Device Identifier: 00821684074046
• UDI-Public: 00821684074046
• 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): 07/02/2018

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: 09/17/2020
• Device Catalogue Number: P4030
• Device Lot Number: A525678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 100