MAUDE Adverse Event Report: 4600 NATHAN LANE NORTH SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	P4028
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the silverhawk was received for analysis.Inserted the cutter driver.The returned silverhawk was inspected - the distal assembly was found to be fractured and separated from the unit.The fracture had occurred approximately 4mm distal the cutter window.The fracture face was ductile in nature.The guidewire tubing was not visible and peeled away.The cutter assembly was observed located within the cutter window with the drive shaft attached.The guidewire tubing was disengaged from the distal assembly.The distal segment which fractured from the unit was not returned.Image review: two images were received for analysis - both attached images were analyzed.Image number 1 showed the distal assembly/distal tip fractured and separated from the shaft of the silverhawk unit.Image number two showed the proximal portion of the unit.The picture showed the hinge assembly and cutter window remain intact.The fracture occurred distal of the cutter window.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to treat a fibrous lesion in the tibial/popliteal trunk using silverhawk atherectomy device.It was reported that the nose cone of the atherectomy device was sheared off inside patient artery and could not be removed with snare.Patient had to go to operating room (or) to get the nose cone removed.The patient was doing well post procedure.
Additional Manufacturer Narrative
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): 4600 NATHAN LANE NORTH; plymouth MN 55442
• MDR Report Key: 6459106
• Report Number: 2183870-2017-00154
• Device Sequence Number: 13608380
• Product Code: MCW
• UDI-Device Identifier: 00821684074039
• UDI-Public: 00821684074039
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: P4028
• Device Lot Number: A337018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR