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

Catalog Number	THS-LX-C
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician had attempted to use a turbohawk atherectomy device to treat a 10cm severely calcified lesion in the mid superficial femoral artery(sfa) and popliteal arteries (80% stenosis).The arteries had moderate tortuosity and the sfa had a diameter of 4-5mm.The device was prepped as per the ifu with no issues identified.The device operated correctly at the beginning of the procedure.It was reported after a pass through calcification the cutter driver locked, could no longer pack and the cutter was unable to return into the housing.The turbohawk was removed from the body and the cutter driver worked normally.An attempt was made to use the device to treat the lesion again and the same issue recurred.Balloon dilation was used to complete the procedure.
Additional Manufacturer Narrative
Device model and lot number corrected.Expiration date, udi and manufacture date included.The cutter was inside the housing when it stopped working.The device was safely removed from the patient.No deformation was noted to the cutter.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the turbohawk was returned connected to a cutter driver and a distal flush tool was inserted over the distal assembly.No other ancillary devices were included.The cutter driver power switch was in the on position.Visual inspection: the turbohawk was inspected and found the torque shaft was bent at an approximate 90 degree bend beneath the strain relief.It was observed the proximal guidewire tubing was flared out and the cutter was advanced within the housing.The proximal end of the guidewire tubing showed the orange colored pi tubing as part of the guidewire assembly detached from the housing.The distal flush tool was removed.The cutter was advanced approximately 2.8cm from the cutter window.Approximately 0.6cm of the guidewire tubing peeled off from the housing with the guidewire tubing material flapped distally.Functional testing: the thumb switch was attempted to be pulled back, but resistance was encountered.After straightening the torque shaft at the strain relief the cutter was able to retract while a clicking noise was heard.Like from the damage to the torque shaft causing the drive shaft and torque shaft to interfere with each other.The cutter was able to retract into the cutter window as intended.The thumb switch was advanced and the cutter advanced approximately 2.6 cm from the cutter window.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7220982
• Report Number: 2183870-2018-00045
• Device Sequence Number: 13788919
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A453120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 02/07/2018; 05/22/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/07/2018; 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1