MAUDE Adverse Event Report: COVIDIEN IRVINE SILVERHAWK ATK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	P4055
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
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
The physician used a silverhawk device to treat a soft tissue lesion with little degree of calcification and 90% stenosis in the mid superficial femoral artery (sfa).The vessel presented little tortuosity.The device was inspected prior to use and prepped with no issued identified.Ifu was followed.It was reported that after one insertion and eight passes, the thumbswitch became jammed.No patient injury reported.
Additional Manufacturer Narrative
Additional information it was possible to turn off the thumbswitch but it had to be held forward to remain off.The cutter was positioned inside the housing for removal of the device from the patient.No deformation was noted in the cutter.A balloon and stent were 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): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8141042
• Report Number: 2183870-2018-00567
• Device Sequence Number: 1887053
• Product Code: MCW
• UDI-Device Identifier: 00821684074145
• UDI-Public: 00821684074145
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 12/06/2018
• Device Catalogue Number: P4055
• Device Lot Number: A385271
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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: 87