MAUDE Adverse Event Report: COVIDIEN ATK TURBOHAWK SMOOTH; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number TH-LX-M

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: two turbohawk devices were returned one of the turbohawk units was connected to a cutter driver.No other ancillary units were included.The turbohawk connected to the cutter driver was inspected.The cutter blank was visible in the cutter window.The edge of the cutter was approximately 0.3cm distal the cutter window.Traces of dried blood/biological debris was observed at the cutter mouth and within the cutter window.The thumb-switch was retracted and the cutter pulled back into the cutter.No damages were noted.The thumb-switch was advanced with the cutter driver activated.The cutter advanced approximately 0.8cm distal the cutter window.It should be noted the cutter stopped at the location of the plunger.A 0.014 guidewire from the lab was inserted the cutter mouth of the distal assembly and pushed the plunger towards the cutter window after the cutter was retracted back into the cutter window.Resistance was first encountered while attempting to push the plunger.The plunger then was able to be pushed back into the cutter window.The thumb-switch was advanced a second time.The cutter was able to advance approximately 2.9cm distal the cutter window.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a turbohawk device for treatment of a slightly calcified soft tissue lesion with little tortuosity in the patients mid superficial femoral artery (sfa).Ifu was followed and the device was prepped and inspected prior to use without issue.It is reported the device became jammed and would not close.The physician could turn the cutter off but not completely forward.The cutter was barely closed when the device was removed from the patient.The same issue is reported for a second turbohawk device used in the procedure.A third device h1-lx was used to complete the procedure.No patient injury reported.

• Brand Name: ATK TURBOHAWK SMOOTH
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7497768
• MDR Text Key: 107705902
• Report Number: 2183870-2018-00268
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684065754
• UDI-Public: 00821684065754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• 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
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2020
• Device Catalogue Number: TH-LX-M
• Device Lot Number: A410449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1