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

Model Number	P4044
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
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
Physician was attempting to use silverhawk directional atherectomy during procedure to treat a moderately calcified lesion in the mid to distal posterior tibial artery (pta) with 40-70% stenosis.The vessel was moderately tortuous.The vessel diameter and lesion length are 2-2.5mm and 150mm respectively.The device was inspected with no issued noted.The device was prepped per ifu with no issues identified.Packaging issue occurred.It was reported that as physician was atherectomies, the thumbswitch would not go into "off" position.As physician was using the atherectomy catheter, after a few passes, the silverhawk would not pack/thumbswitch would not go into "off" position.The device was removed, flushed and cleaned as per ifu but the problem persistent when it was outside of the patient.Physician tried reconnecting catheter to cutter driver, submerging nosecone in saline and turning it on, but the problem persisted.Physician pushed the thumbswitch keeping fort into off position and cutter driver turned off, the cutter was outside the housing when removed from patient.The device was safely removed from patient.There was no intervention required to remove device.A new catheter was opened to proceed.There was no patient injury.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12445384
• Report Number: 9612164-2021-03468
• Device Sequence Number: 14365391
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: 06/09/2023
• Device Model Number: P4044
• Device Catalogue Number: P4044
• Device Lot Number: 0010713603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1