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

Catalog Number	P4052
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	03/05/2018
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
The physician was attempting to use a silverhawk directional atherectomy catheter to treat a plaque lesion with little calcification in the proximal sfa-popliteal artery (80% stenosis).The artery was non-tortuous.The device was prepped as per the ifu with no issues identified.The vessel was not pre or post dilated.During the initial advancement severe resistance was encountered.The blade of the device could not be released.The tip of the device embolised and was captured within the sheath.A new silverhawk was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: the silverhawk atk was returned for analysis.No other ancillary devices were included.The silverhawk was inspected and observed the cutter was within the cutter window of the distal assembly.Damage was noted on the cutter head.Biological material was observed within cutter window and on the cutter assembly.The cutter assembly was soaked in water.Under microscope it was discovered approximately 25% of the circumference of the distal rim of the cutter head was broken off.The piece which had broken off, was not returned with the silverhawk unit.The thumb-switch was pushed forward and the cutter impacted the distal rim of the cutter window (cutter crash).Event update: severe resistance was encountered during thumbswitch advancement.The thumbswitch was unable to open/ close the cutter.It was reported an unfamiliar sound was emitted from the motor and the motor experienced issues turning on and off.No intervention was required.Guidewire prolapse did not occur.The tip did not separate at the hinge pin.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: 7395126
• Report Number: 2183870-2018-00202
• Device Sequence Number: 10958741
• Product Code: MCW
• UDI-Device Identifier: 00821684074121
• UDI-Public: 00821684074121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 07/15/2018
• Device Catalogue Number: P4052
• Device Lot Number: A311250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR