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

Catalog Number	THS-SS-CL
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection: the turbohawk was removed from the packaging and was inspected.A zipper tear was noted in the guidewire lumen of the distal assembly.Microscopic inspection revealed a zipper tear throughout the guidewire lumen of the housing.Examination of the rotating tip showed the guidewire lumen at the proximal end flared out and the guidewire lumen was peeled back distally.Green debris, consistent with ptfe coating on the reported guidewire, was noted between the guidewire lumen of the rotating tip and the housing assembly and the distal end of the rotating tip lumen tear.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a turbohawk to treat a severely calcified lesion with 90% stenosis located in the proximal/mid/distal right posterior tibial artery.Artery diameter 2.5 ¿ 3 mm.Moderate tortuosity was reported.A 6fr cook sheath and a cook 300 mm approach 25 cto guidewire were used.The vessel was pre-dilated.The ifu was followed and the guidewire was hydrated during prep.The device was advanced over the bifurcation.Atherectomy was completed and artery was post-dilated with no issue.It was reported that the black wire on the body of the device split.The tip was the only piece which remained on the wire.The device was intact and some difficulty was encountered removing the device.The guidewire was not torn from the distal tip and the guidewire did not lock-up on the catheter.The split was reproduced outside of the patient.No patient injury was reported.The device was returned to the manufacturing facility and it was noted that the device was damaged.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8639686
• Report Number: 9612164-2019-01943
• Device Sequence Number: 16809932
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170191
• 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): 05/24/2019

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: 10/03/2021
• Device Catalogue Number: THS-SS-CL
• Device Lot Number: 0009361368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 77