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

Catalog Number	P4044
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use one silverhawk directional atheterctomy device to treat a slightly tortuous and moderately calci fied lesion located in the tibial/popliteal trunk.The device was removed from its packaging and inspected with no issues noted.The device was prepped per the ifu.It was reported that the cutter window jammed during the procedure and that the physician was unable to close the window during cutting.The physician was unable to return the cutter to the housing before the device was removed from the patient.The physician removed the device and used a new device to complete the procedure.No patient injury was reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvice CA 92618
• MDR Report Key: 6950203
• Report Number: 2183870-2017-00448
• Device Sequence Number: 10987819
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• 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
• Report Date (Section B): 09/14/2017

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: 04/20/2019
• Device Catalogue Number: P4044
• Device Lot Number: A448024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1