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

Catalog Number	P4030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image analysis summary: the silverhawk directional atherectomy system was not received for evaluation.Two photographic images included with the initial reported event were provided for evaluation.The two photographic images show a silverhawk directional atherectomy distal assembly with the guidewire zippered/torn from the distal assembly.The photographs confirm the customer experience of the guidewire lumen becoming shredded and out of position.Due to the quality and clarity of the image the pin separation at the hinge in the distal assembly cannot be confirmed.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
Physician was using a silverhawk btk with a size 6f non-medtronic sheath and a size.014 non-medtronic guidewire for the treatment of a moderately calcified plaque lesion in the left proximal mid tibial/popliteal trunk which exhibited little tortuosity and 70-90% stenosis.The ifu was followed.During advancement of the silverhawk into the pt trunk/peroneal region, moderate resistance was met.It was reported that when physician attempted to rotate the device and observed that the wire port came out through the distal portion of the device.The wire port which the device is advanced over shredded and came out of placement.Tip separated at the hinge pin.No device component was lost in the patient.Procedure was not completed.Physician terminated intervention of the vessel.No injury to patient was 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: 6628993
• Report Number: 2183870-2017-00245
• Device Sequence Number: 13691592
• 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): 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: 11/14/2019
• Device Catalogue Number: P4030
• Device Lot Number: A375510
• 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
• Outcome Attributed to Adverse Event: Other