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

Catalog Number THS-SX-C

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8377243
• MDR Text Key: 137362750
• Report Number: 9612164-2019-00725
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968226
• UDI-Public: 00643169968226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 97