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

Catalog Number	P4056
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
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
It was reported that the physician intended to use the silverhawk directional atherectomy device to treat a soft tissue lesion, with little tortuosity, no calcification and 99% stenosis in the mid superficial femoral artery(sfa) as per ifu.The device was prepped per ifu with no issues identified.It was reported after two passes the device jammed and became excessively difficult to close.No injury to the patient was reported.
Additional Manufacturer Narrative
The thumbswitch stopped functioning in the patient immediately following the second pass.The thumbswitch was successfully turned off but excessive force was required.The cutter was positioned inside the housing and the power was turned off.The device was safely removed 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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8063633
• Report Number: 9612164-2018-03159
• Device Sequence Number: 16621840
• Product Code: MCW
• UDI-Device Identifier: 00821684074169
• UDI-Public: 00821684074169
• 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): 12/11/2018

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: 11/03/2018
• Device Catalogue Number: P4056
• Device Lot Number: A370139
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 76