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

Catalog Number	P4055
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	07/11/2019
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
It was reported that the physician was using a silverhawk atk device during treatment of a 50 mm calcified 70% stenotic lesion in the patient¿s mid left superficial femoral artery (sfa) of diameter 6 mm.No tortuosity and moderate calcification were reported.The device was prepped per ifu without issue.It was reported that device broke and the nosecone separated just distal to the cutter window.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: the silverhawk device was returned for analysis.No ancillary device or images were received.The device was removed from the packaging for visual inspection.The cutter driver was not returned.The distal housing was noted to be separated from the torque shaft at the hinge pin.The cutter was advanced approximately 3.4cm distal to the hinge weld.The distal assembly remained attached to the device due to the cutter which was unable to be pulled from the cutter window.Microscopic inspection of the hinge revealed one of the welds was torn proximally, the other weld remained intact.Inspection of the inside of the housing revealed evidence of weld on both weld spots.Microscopic inspection revealed no anomalies to the cutter or the cutter window.Inspection of the hinge pins revealed that one of the hinge pins was damaged and deformed.The pin was pointing proximally.The proximal collar of the housing exhibited a flaring.No damage was noted to the additional hinge pin weld.Both hinge pins were accounted.Microscopic inspection of the of guidewire lumen revealed no anomalies.A 0.014¿ guidewire from the lab was inserted into the guidewire lumen; no resistance or anomalies were noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the issue is reported to have occurred during first activation of the device.The tip did not separate at the hinge pin.The tip is reported to have detached in the vessel.No intervention was required to remove the detached tip from the patient.A second silverhawk was used to complete the procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8784225
• Report Number: 9612164-2019-02834
• Device Sequence Number: 16570970
• Product Code: MCW
• UDI-Device Identifier: 00643169968431
• UDI-Public: 00643169968431
• 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,Followup
• Report Date (Section B): 09/16/2019

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: 02/19/2021
• Device Catalogue Number: P4055
• Device Lot Number: 0009603218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 09/14/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/21/2019; 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85