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

Catalog Number	P4030
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk device was inspected and found the orange distal guidewire tubing disengaged from the proximal torque shaft guidewire tubing.The distal guidewire tubing was not torn; however buckling was noted approximately 0.3 mm from the proximal end of the distal guidewire tubing.The proximal guidewire tubing was inspected and discovered zipper tearing throughout the entire segment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the silverhawk directional atheterctomy device as per ifu, to treat a cto in the superficial femoral artery.A non-medtronic.014 300 guidewire and a 6 fr non-medtronic sheath were used.Artery diameter 6mm lesion length 100mm.It was reported the device was advanced to the lesion, made 2 passes with no issues noted.During removal of the device the physician encountered resistance, fluoro image showed a prolapsed wire in proximal sfa at the distal section of the device.The physician advanced the wire to straighten.The wire and device were removed intact as a unit.The wire was removed from the proximal port, a deformity was observed.No patient injury was reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7137134
• Report Number: 2183870-2017-00606
• Device Sequence Number: 18855378
• 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
• Report Date (Section B): 12/20/2017

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: 12/19/2019
• Device Catalogue Number: P4030
• Device Lot Number: A391677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 69