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

Catalog Number	P4056
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the silverhawk was returned for evaluation along with three detached cutter driver.Two cutter drivers had medtronic printed and the other had ev3 printed.No other ancillary devices were included.The silverhawk was inspected.The cutter was located back within the cutter window.No damage or anomalies to the silverhawk were noted.The distal assembly was inspected under microscope and a piece of metal protruding out from the cutter window, behind the cutter head, was identified.The piece of metal appeared to be a strut from a stent.The piece was attempted to be removed using a tweezers, however resistance was encountered.Direct light applied to the cutter housing observed the plunger was pushed to the proximal end of the housing against the distal rim of the cutter assembly.The silverhawk was connected to a returned cutter driver and activated.The cutter was able to be advanced into the housing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a silverhawk atk with a protégé ef as per the ifu to treat a fibrous lesion with a small degree of calcification and with 80% stenosis in the mid superficial femoral artery.No abnormalities were reported in relation to the patients anatomy.The lesion had a length of 200mm and the artery had a diameter of 5mm.The procedure used a non medtronic 7fr sheath and an ev3 nitrex 0.014 300cm guidewire.The lesion was predilated with a 5 x 150mm device.The device was prepped with no issued identified.It was reported that the device did not pass through a previously deployed stent.No resistance was reported when advancing the device nor was excessive force used.It was reported the packing mechanism of the silverhawk jammed and would not close.The blade returned into the housing before it was removed from the patient.The physician reported that a 7 x 120 everflex stent was advanced over the wire to the target lesion.The md determined the stent he requested was too long and was he not comfortable deploying this stent.He subsequently removed the undeployed 7 x120 stent and replaced it with a 7 x100 everflex stent.After seeing the 7 x 100 stent under fluoroscopy, he determined the 7 x 100 length was appropriate length for the target lesion and deployed.No patient injury was reported.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA
• MDR Report Key: 7909169
• Report Number: 2183870-2018-00449
• Device Sequence Number: 16480376
• Product Code: MCW
• UDI-Device Identifier: 00643169968448
• UDI-Public: 00643169968448
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120129
• 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): 09/26/2018

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: 01/31/2019
• Device Catalogue Number: P4056
• Device Lot Number: A407750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1