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

Catalog Number	THS-LX-C
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
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
Physician attempted to use a turbohawk to treat a fibrous lesion with 100% stenosis in the mid right superficial femoral artery (sfa).Ifu was followed.It was reported that the device could not pack inside the patient but it moved freely outside the patient¿s body prior to placing into the patient.The packer would not advance after the second packing stage and the device was full.The physician cannot confirm if it correctly packed during first pass.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received: no noticeable unfamiliar sounds were emitted from the device.When the device was removed from the patient the thumbswitch was observed to be working but the packer was not advancing.Possible deformity noted, but it is unsure when this occurred.The physician completed the procedure by ballooning some areas.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation visual inspection: the turbohawk was inspected and observed biological debris within the housing inner diameter.The cutter was positioned retracted back into the cutter window.No damage to the housing was identified.Functional testing: the turbohawk was connected to the cutter driver and the powered on.The cutter driver activated as intended.The thumb switch was pushed forward and encountered resistance.The cutter advanced approximately 1 cm from the cutter window.A distal flush tool was placed over the distal assembly and was flushed with water.The thumb switch was advanced a second time, but the cutter stopped at 1 cm from the cutter window.The distal assembly was soaked in water for approximately 24 hours.The distal assembly was flushed and then attempted to advance the cutter with the cutter driver activated.The cutter stopped at 1 cm from the cutter window.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: 8222631
• Report Number: 9612164-2019-00087
• Device Sequence Number: 211279
• Product Code: MCW
• UDI-Device Identifier: 00643169968400
• UDI-Public: 00643169968400
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 03/20/2019

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: 09/16/2021
• Device Catalogue Number: THS-LX-C
• Device Lot Number: 0009328828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/12/2019; 03/15/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/05/2019; 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR