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

Catalog Number	P4044
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
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
It was reported that a physician was attempting to use a silver hawk btk device to treat the right (mid-distal) peroneal artery that was calcified and plaqued with no tortuosity and 80-90% stenosis in a patient.Artery diameter and length were 2.5mm and 350mm respectively.There was no abnormality reported in relation to the anatomy.Once the treatment was completed, the thumbswitch would not move forward into off position.Once removed from the patient, device was cleaned per ifu and the problem persisted.Physician was unable to turn it off and the motor was running.A new cutter driver was used to solve the problem, but the thumbswitch still would not close.It was reported that it was jammed/will not close.A brand new catheter was used to continue the procedure.No patient injury was reported for this event.
Additional Manufacturer Narrative
Device evaluation the silverhawk was removed from the packaging and inspected.The cutter was located retracted back into the cutter window.Under microscope, the distal rim of the cuter window was bent.No other damages or anomalies were noted.The cutter was retracted back into the cutter window and observed trace amounts of dried biologics on the rim of the cutter.Functional testing.The silverhawk was connected to a cutter driver from the lab and activated.After activation, the thumb switch was pushed forward; however, resistance was encountered immediately.It was discovered the cutter was making contact with the distal rim of the cutter window, which led to a cutter crash (photo 10-11).It was observed under microscope the distal rim of the cutter window was pushed in towards the inner diameter of the housing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a non-medtronic 6fx45cm sheath and 0.014 x300cm guidewire were also used.The cutter driver/thumbswitch stopped functioning while in use in patient.The cutter was observed to be outside of the housing.No deformation was noted to the cutter.Following safe removal of the device from the patient an angiographic image was taken to confirm the vessel safety.No issues identified.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): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8342948
• Report Number: 9612164-2019-00530
• Device Sequence Number: 14030356
• Product Code: MCW
• UDI-Device Identifier: 00643169968479
• UDI-Public: 00643169968479
• 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,Followup,Followup
• Report Date (Section B): 05/20/2019

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: 10/03/2020
• Device Catalogue Number: P4044
• Device Lot Number: 0009360819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/22/2019; 05/10/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/13/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1