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

Catalog Number	P4055
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a silverhawk directional atherectomy catheter during procedure.A 7fr 45cm sheath and.014 guidewire for the treatment of a moderately calcified lesion in the left mid superficial femoral artery which displayed a moderate degree of tortuosity.The device was prepped as per ifu.Minimal resistance was felt during advancement.The tip detached at the hinge pin during advancement of device through sheath.The device was removed and a new device was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
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: 6574202
• Report Number: 2183870-2017-00212
• Device Sequence Number: 613631
• Product Code: MCW
• UDI-Device Identifier: 00821684074145
• UDI-Public: 00821684074145
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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: 05/25/2018
• Device Catalogue Number: P4055
• Device Lot Number: A284077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1