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

Catalog Number	P4044
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	10/27/2017
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 one silverhawk btk directional atherectomy device to treat a mid-right posterior tibial artery lesion, exhibiting (b)(4) stenosis.The lesion was not predilated.The ifu was followed during prep, procedure and post procedure.It was reported that resistance was not felt, the distal tip was damaged and did not allow the cutter blade to fully open & close.The cutter detached from the driveshaft while packing down in the nosecone.When the physician then attempted to activate the cutter, it would not come back to the cutter window and remained in the nosecone.The tip did not separate at the hinge pin.The physician completed the procedure using a new device.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk was returned without a cutter driver.No ancillary devices were included.The silverhawk was inspected and observed the cutter was advanced within the laser drilled segment of the distal assembly.There was no indication the cutter assembly was not connected to the drive shaft.Dried blood was observed within the distal assembly; however no damages were noted.The silverhawk was inserted a cutter driver from the lab.The cutter driver was activated and the thumb-switch retracted.The cutter assembly was pulled back into the cutter window as intended.No damages were observed to the visible cutter assembly.The thumb-switch was pushed forward and the cutter advanced approximately 1.7 cm distal the cutter window.There was no evidence the cutter assembly separated from the drive shaft.The cutter was able to retracted and advanced as intended during lab testing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 7057129
• Report Number: 2183870-2017-00528
• Device Sequence Number: 10794789
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/18/2017

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: 07/28/2019
• Device Catalogue Number: P4044
• Device Lot Number: A499571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/23/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR