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

Model Number THS-SX-C

Device Problems Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Image review the customer provided three cine images.Each image has been evaluated.The first image reviewed shows the distal assembly within the vessel over a guidewire.The customer provided two additional cine images, however, neither image could identified a turbohawk component within the vessel.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the turbohawk was returned with a detached cutter driver inside a previously opened pouch which indicated lot 0009537001.No other ancillary devices were included.An inspection of the turbohawk and cutter driver found no damages or anomalies that would appear to have contributed to the reported event.The cutter was advanced within the cutter assembly housing.The length of the housing assembly was approximately 6cm long in accordance with the product labeling tip length of 5.9cm.The cutter was advanced within the housing.The rotating tip guidewire lumen not positioned aligned with the housing.A 0.014" guidewire was front-loaded the distal assembly.The guidewire was able to go through both lumen after aligning the tip assembly with the housing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: there was no tip separation at the hinge pin.After the device was prepped, when loading the device into the wire, the device would not stay lined up, with the black line lined up with the black line at the distal tip.The distal white nosecone tip would not line up with the packaging line on the nosecone.When entering the wire, the wire would not go into the correct alignment due to the fact that the distal tip would not lineup, which would cause it to go into the wrong port lumen.The wire kept coming out on the exit port instead of going into the nosecone lumen port.When the new device was prepped, it went over the wire correctly without any problems.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: no detachment occurred.The device did not enter the patient's body.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

The physician attempted to use a turbohawk device with non-medtronic.014¿ guidewire and 6f sheath to treat a 40mm calcified lesion in the patients left mid popliteal artery.Vessel diameter is reported as 5mm.Moderate degree of calcification and moderate degree of tortuosity reported.The ifu was followed.Size 4 spider embolic protection was used.The vessel was post-dilated.Resistance was felt during advancement, tip was damaged and would not allow device to advance over the guide wire.It was reported that the tip separated at the hinge pin.The procedure was completed using another turbohawk and a nanocross balloon.There was no injury to the patient.

• 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: 9601129
• MDR Text Key: 188426241
• Report Number: 9612164-2020-00288
• 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,Followup,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: THS-SX-C
• Device Catalogue Number: THS-SX-C
• Device Lot Number: 0009537001
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• 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 Age: 75 YR
• Patient Weight: 127