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

Catalog Number	P4052
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
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 for the treatment of a moderately calcified lesion exhibiting 95% stenosis in the right proximal superficial femoral artery (sfa).The vessel was not reported to be tortuous.The ifu was followed and the device was prepped with no issues noted.It is reported after completing 4 passes, the thumbswitch became stuck in the on position.The cutter was outside of the housing when it crashed but was able to get inside the housing when the tech held forward pressure on the thumbswitch after the power was turned off to remove the device safely form the patient.No deformation was noted to the device on removal from the patient.Following removal, the thumbswitch remained in the on position after cleaning the device preventing the physician from making any more passes.No patient injury reported.The procedure was completed using stenting.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7482413
• Report Number: 2183870-2018-00253
• Device Sequence Number: 1543147
• Product Code: MCW
• UDI-Device Identifier: 00821684074121
• UDI-Public: 00821684074121
• 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
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2018
• Device Catalogue Number: P4052
• Device Lot Number: A379919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81