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

Catalog Number	P4030
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the silverhawk device was returned for evaluation.No ancillary device or images were received.The silverhawk was removed from the packaging.The device was returned detached from the cutter driver, the cutter driver was not returned.Inspection of the distal assembly revealed the white guidewire lumen was torn and detached from approximately 3.7cm proximally from the distal end of the guidewire lumen.A portion of the lumen remained attached.Approximately 1.2cm section of white guidewire lumen at the proximal end remained attached with no anomalies.Microscopic examination of the distal assembly revealed the orange guidewire lumen was detached.The distal marker band was also detached from the distal tip.The distal marker band and orange guidewire lumen were not returned with the device.The cutter was returned just distal to the cutter window.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a silverhawk directional atherectomy along with non-medtronic 6fr sheath and non-medtronic.014 guide wire to treat a vessel.The vessel was not pre dilated.Ifu was followed during preparation, procedure and post procedure.The guide wire was hydrated at preparation.The guide wire did not have difficulty accessing ports and the device was not advanced over a bifurcation.It was reported that during advancement, minimal resistance was felt.The guide wire lumen was torn from the distal tip which caused guide wire lock-up on catheter.Upon loading the atherectomy catheter on the guide wire, the device hung up on the wire not allowing device to advance across the guide wire.The guide wire was pulled from lumen with resistance.There was no damage to the guidewire tip.Another silverhawk ss+ was used to complete the procedure.There was no patient injury reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9509201
• Report Number: 9612164-2019-05287
• Device Sequence Number: 430248
• Product Code: MCW
• UDI-Device Identifier: 00643169968462
• UDI-Public: 00643169968462
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/23/2019

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: 04/02/2022
• Device Catalogue Number: P4030
• Device Lot Number: 0009677699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1