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

Catalog Number	P4044
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
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 intended to use a silverhawk during treatment of a calcified lesion in the patient¿s mid anterior tibial artery.Moderate calcification and tortuosity are reported.Lesion exhibited 75% stenosis.Ifu was followed.Pre-dilation not performed.It is reported the blade would not advance back into the housing unit.The device was replaced to complete the procedure.No injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It is reported during use in the patient the thumbswitch would not turn off.The device was safely removed from the patient, no deformation was observed to the cutter.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: 8649025
• Report Number: 9612164-2019-02057
• Device Sequence Number: 2340435
• 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): 08/23/2019

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: 02/19/2021
• Device Catalogue Number: P4044
• Device Lot Number: 0009603215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 08/22/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/26/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1