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

Catalog Number	P4030
Medical Device Problem Codes	Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk device was returned for evaluation.No ancillary devices were included.The silverhawk was inspected and observed the orange guidewire tubing was protruding out from the distal assembly.The torque shaft guidewire tubing showed a zipper tear throughout the component.No tearing of the orange tubing was noted, however a bend of approximately 45degrees was noted.A 0.014" guidewire from the lab was attempted to be back-loaded.Verified the tear occurred throughout the whole section of the torque shaft guidewire tubing.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 used a silverhawk directional atherectomy device to treat a plaque lesion in the right mid sfa.The lesion was described as having little calcification, 80 mm in length with 80% stenosis.The artery was 6 mm in diameter with little tortuosity.The device was prepped as per the ifu with no issues identified.A 0.014"non-medtronic guidewire was used with a 6 fr non-medtronic sheath.No embolic protection was used.It was reported upon removal of the device, a wire was noted to be hanging from the working portion of the device along the nosecone or cutter window.No resistance was experienced during advancement or withdrawal.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: 6881667
• Report Number: 2183870-2017-00410
• Device Sequence Number: 13643536
• 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): 08/22/2017

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: 06/27/2020
• Device Catalogue Number: P4030
• Device Lot Number: A483286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR