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

Catalog Number	P4044
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	05/15/2019
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 used a silverhawk btk device to treat a fibrous moderately calcified, moderately tortuous 80% lesion in the patient¿s mid tibial/popliteal artery.The ifu was followed and the device was prepped without issue.The vessel was not pre-dilated.Moderate resistance was felt during withdrawal.It was reported that the tip became damaged and detached.It did not separate at the hinge pin but became entangled in wire.Balloon angioplasty was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the tip did not completely detach in the patient.An evercross was used to complete the procedure without further incident.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the silverhawk device was returned for evaluation.No ancillary device or images were received with the device.The device was removed from the packaging for investigation.The cutter driver was not returned with the device.Biological debris was found throughout the distal assembly.Multiple bends were noted throughout the distal assembly, the clear tip was curved upward.The distal rotating tip was detached and separated from the distal assembly; the rotating tip was not returned with the device.The clear distal end was torn.The guidewire lumen was noted to be disengaged from the distal housing; the guidewire lumen was not returned.The cutter was returned advanced approximately 1.5cm distal to the cutter window.Distal assembly measured 4.5cm.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): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8631084
• Report Number: 9612164-2019-01884
• Device Sequence Number: 13907321
• Product Code: MCW
• UDI-Device Identifier: 00643169968479
• UDI-Public: 00643169968479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/13/2019

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: 02/24/2021
• Device Catalogue Number: P4044
• Device Lot Number: 0009611752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/22/2019; 08/09/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/28/2019; 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1