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

Model Number THS-SS-CL

Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a turbohawk btk device with a 6fr sheath during treatment of a plaque lesion in the patient¿s mid left anterior tibial artery.Moderate vessel tortuosity and calcification are reported.Lesion exhibited 90% stenosis.The lesion length was 40 mm.Ifu was followed.Pre-dilation was not performed.No embolic protection was used.Resistance was felt during advancement of the device.It is reported the device was sticking while trying to torque and then would spin in the artery without any passes made with the device.No treatment was given with this device.The device was safely removed from the patient with the cutter blade inside the housing.The artery was stented to complete the procedure, which was not part of the planned original procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the device was returned to medtronic investigation lab for evaluation.There were no ancillary devices or images returned.There was a slight bend in the torque shaft beneath the strain relief.Biological debris was noted within the distal housing.It was noted that the cutter driver was returned in the "on" position.The cutter was returned just distal to the cutter window.No damage was noted to the guide wire lumen upon inspection.A 0.014" guide wire was back loaded onto the turbohawk device.No anomalies or resistance was noted during insertion of the guide wire.The od of the device was taken.The device and guide wire were then inserted into a 6 fr sheath.No anomalies were noted during insertion.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: 9339761
• MDR Text Key: 167115744
• Report Number: 9612164-2019-04787
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968202
• UDI-Public: 00643169968202
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: THS-SS-CL
• Device Catalogue Number: THS-SS-CL
• Device Lot Number: 0009791497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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: 65 YR
• Patient Weight: 98