MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK CALCIUM; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	THS-LX-C
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	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a turbohawk to treat a severely calcified lesion in the right proximal superficial femoral artery (sfa).Little tortuosity was reported in the vessel.The device was inspected and prepped per ifu with no issues.It was reported that the patient suffered a perforated vessel due to the lesion being calcified.The physician used a balloon to treat the perforation.During cleaning of the device, a second time in preparation to use it again in the patient, the shaft of the device broke and detached at the hub.A second device was used to complete the procedure.
Additional Manufacturer Narrative
Device evaluation: the turbohawk was inspected and observed the torque shaft was disengaged from the shaft adapter assembly.The approximate length of the detached catheter shaft was approximately 85cm (photo 6-8).The distal assembly showed biological material within the housing.Under microscope the torque shaft was separation occurred was checked.The torque shaft fracture face indicated a ductile fracture.The rotator assembly was inspected after removing the strain relief.After removing the strain relief, the exposed drive shaft distal the hypotubing showed a ductile fracture face.Image review: the customer provided two photos of the turbohawk unit post-procedure.Both photos show the rotator assembly detached from the torque shaft.The nature of the separation could not be determined from the photo alone.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8500110
• Report Number: 9612164-2019-01272
• Device Sequence Number: 14049396
• Product Code: MCW
• UDI-Device Identifier: 00643169968400
• UDI-Public: 00643169968400
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111723
• 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): 06/27/2019

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: 01/06/2022
• Device Catalogue Number: THS-LX-C
• Device Lot Number: 0009524711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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