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

Catalog Number	P4028
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	10/07/2019
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
Physician was using silverhawk along with non medtronic 6fr sheath and guide wire to treat a moderately calcified lesion in the right distal tibial/popliteal trunk with chronic total occlusion (cto-100%).The vessel was moderately tortuous with 4 mm diameter.The vessel was pre dilated but not post dilated.Ifu was followed during preparation, procedure and post procedure.It was reported that the device tip detached during withdrawal.Moderate resistance was felt and the nosecone detached.The silverhawk was used to shave the distal popiteal and pt trunk.After shaving, the device was inside the sheath coming across the external iliac and the nosecone separated and remained in the sheath after the catheter was removed.The nosecone remained on the wire inside the sheath until the sheath was removed.A non medtronic device was used to complete the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: it could not be visualized if the tip separated at the hinge pin but angiographically, no parts were visualized in the patient.The device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device return the silverhawk was inspected and it was discovered the distal assembly was fractured apart.The fracture occurred approximately 1cm distal the cutter window.The length of the distal assembly fractured off was approximately 2cm.The guidewire tubing showed zipper tearing.The fracture face was ductile in nature.The torque shaft gw tubing showed zipper tearing.The cutter assembly was located within the cutter window.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: 9166673
• Report Number: 9612164-2019-04273
• Device Sequence Number: 14107180
• Product Code: MCW
• UDI-Device Identifier: 00643169968455
• UDI-Public: 00643169968455
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/10/2020

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: 04/23/2021
• Device Catalogue Number: P4028
• Device Lot Number: 0009103989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 01/09/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/11/2019; 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR