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

Catalog Number	THS-SX-C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/25/2019
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 using a turbohawk device to treat a 5mm moderately calcified lesion with 90% stenosis in the mid right common iliac artery.Severe tortuosity was reported in the 8mm diameter artery and steep bifurcation.A 6 x 45 non-medtronic sheath and an 0.014 non-medtronic guidewire was used.The ifu was followed and the guidewire was hydrated during prep.The device was advanced over the bifurcation.It was reported that during the procedure moderate resistance was felt during both advancement and withdrawal of the device.The guidewire locked up on the catheter and the guidewire lumen was torn from the distal tip.The flush port on the catheter handle was not damaged.There was damage to the tip and the tip of the device detached.The tip of the device remained in the patient and was caged to the wall of the iliac using a visipro stent.
Additional Manufacturer Narrative
Device evaluation: the turbohawk showed a radial fracture distal to the anchor pockets of the distal assembly and at the proximal edge of where the laser drilled coils initiated.It should be noted the pet disengaged from the housing.The distal assembly which had fractured off was not included.The cutter was advancing out and the cutter and driver shaft were exposed by approximately 2.6 cm.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8377243
• Report Number: 9612164-2019-00725
• Device Sequence Number: 2887747
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K103618
• 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): 05/23/2019

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: 01/02/2022
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0009518913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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
• Patient Age: 78 YR
• Patient Weight: 97