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

Catalog Number	P4052
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/13/2018
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 intended to use the silverhawk with a 7f non-medtronic sheath and a spider fx 6mm, to treat a soft tissue lesion with 80-90% stenosis in the left superficial femoral and popliteal arteries.Artery diameter 5mm, lesion length 150mm, device was inspected and prepped as per ifu with no issues noted.The vessel was not pre-dilated, no resistance was encountered.It was reported the tip of the silverhawk detached; the cutter housing parted from the shaft.The physician opened a second silverhawk and reported that the thumb switch was sticking and could not be pushed all the way forward.The physician completed the procedure with the second device.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: email address film analysis the customer provided a photo of the silverhawk unit with the tip separated.The housing of the distal assembly appears to be separated at the hinge location.The distal detached segment remains as part of one unit with the silverhawk.The drive shaft is exposed, holding the separated housing to the silverhawk unit.Product analysis two silverhawk units were returned.One unit showed a cutter driver attached.No other ancillary devices were included.During visual inspection it was identified that the distal assembly separated from the silverhawk at the torque shaft adapter.Approximately 2.5cm of the distal assembly was exposed between the distal assembly and torque shaft adapter.No damage to the guidewire lumen was identified.The torque shaft adapter showed no damages or anomalies.The distal assembly was inspected and verified both hinge pins were intact.The platinum iridium of the housing was bent outward and one of the hinge pin locations, causing the hinge pin to point in a proximal direction.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the tip of the first silverhawk was damaged but did not completely detach from the catheter.This occurred where the shaft meets the cutter.It was reported that the second silverhawk was removed safely from the patient but it was unknown if the cutter returned to the housing prior to removal.No deformation was observed in the cutter after it was removed.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: 8099854
• Report Number: 2183870-2018-00530
• Device Sequence Number: 2035328
• Product Code: MCW
• UDI-Device Identifier: 00821684074121
• UDI-Public: 00821684074121
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2019

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: 11/22/2018
• Device Catalogue Number: P4052
• Device Lot Number: A379918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 01/31/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 12/04/2018; 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78