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

Catalog Number	P4055
Medical Device Problem Codes	Difficult to Flush (1251); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
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
Physician used a silverhawk device with a 7fr sheath and 0.014 wire during treatment of a fibrous lesion in the patient¿s distal left superficial femoral artery (sfa).No tortuosity or calcification reported.Ifu was followed.Device prepped without issue.Pre-dilation was performed.It is reported that during the procedure, difficulty was experienced when trying to flush tissue.The thumb switch on the cutter driver would fully transition into the on and off positions.The cutter driver was released from the catheter and reattached.A new cutter driver was then connected.Due to the inability to fully open and close the cutter window due to the thumb switch, plaque was not able to be flushed from the nosecone.No damage noted to device.A second atherectomy device as opened to complete the procedure.No injury reported.
Additional Manufacturer Narrative
Additional information: the thumbswitch on the cutter driver could not be completely turned off, it would not fully transition into the on and off positions.The device was safely removed from the patient.The cutter was inside the housing for removal, but the cutter window could not completely close.No deformation noted in the cutter 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: 8887204
• Report Number: 9612164-2019-03363
• Device Sequence Number: 2514350
• 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
• Report Date (Section B): 08/14/2019

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: 01/16/2021
• Device Catalogue Number: P4055
• Device Lot Number: 0009543498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1