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

Catalog Number	P4044
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
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
It was reported that the physician intended to use a silverhawk device.The device was prepped as per the ifu with no issues identified.While in use in the patient, the cutter is reported to have jammed.It was not possible to get the switch into a full off position.The cutter was reported to have been caught in the middle of the housing, leaving some of it exposed.The device was safely removed from the patient and no deformation was noticed on the cutter.No patient injury was reported.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7995395
• Report Number: 9612164-2018-02882
• Device Sequence Number: 1669808
• Product Code: MCW
• UDI-Device Identifier: 00643169968479
• UDI-Public: 00643169968479
• 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
• Report Date (Section B): 10/23/2018

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: 08/20/2020
• Device Catalogue Number: P4044
• Device Lot Number: 0009288775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1