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

Model Number	P4030
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the silverhawk was returned with no ancillary devices.The silverhawk was inspected and found the orange guidewire (gw) lumen protruding out from the torque shaft assembly.The orange gw tubing remained bonded to the distal are of the distal assembly but was noted the orange gw tubing was bent at the location where it loads into the distal area.The torque shaft gw tubing showed a longitudinal zipper tear.Traces of dried blood was observed throughout the device.No other damages or anomalies were noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a 0.014 nitrex guidewire was also used during the procedure.It was not known if the silverhawk got caught on the bifurcation, the physician was looking distal in the sfa at the time of crossing.No previously deployed stent at the bifurcation.Following removal of the silverhawk and nitrex wire, a kink was observed in the nitrex wire and it was replaced.No injury to patient¿s vessel.No removal issues were noted in the description, both the wire and silverhawk were removed together.Nitrex was fully intact upon removal.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was using silverhawk directional atherectomy during procedure to treat a severely calcified lesion in the right proximal common iliac artery with 90% stenosis.The vessel diameter and lesion length are 6mm and 30mm respectively.Device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported that a non medtronic sheath was used and placed at bifurcation, would not go to right side of iliac artery.The silverhawk was advanced and upon moving over bifurcation, device was caught near bifurcation and wire lumen with the wire went up into aorta.The wire and device were removed without any issues.The whole device was inspected with all parts present.The lumen was stripped from device and a hawkone was used and procedure completed without any issues.There was no patient injury reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9563654
• Report Number: 9612164-2020-00148
• Device Sequence Number: 2866289
• Product Code: MCW
• UDI-Device Identifier: 00643169968462
• UDI-Public: 00643169968462
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

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: 04/08/2022
• Device Model Number: P4030
• Device Catalogue Number: P4030
• Device Lot Number: 0009684741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/08/2020; 02/27/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/09/2020; 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 73