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

Catalog Number	THS-LX-C
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a turbohawk device for treatment of a moderately calcified plaque 70% stenosed 160mm lesion in the patients mid/distal superficial femoral artery(sfa)/popliteal artery(pa).Little tortuosity was reported and a vessel diameter of 5-6mm was noted.The ifu was followed.It was reported that the device was prepped and used without issue.The turbohawk was able to open and close the cutter but the cutter could not be pushed into the housing.Strong resistance was encountered when the thumbswitch was pushed forward.The thumbswitch needed to be pushed several times to cut the plaque but the cutter could not completely enter the housing.The device was removed successfully, and physician checked that there were no hinderance from foreign bodies.When the device was taken out, the head of the cutter was recovered partly.The device was replaced with another turbohawk and the procedure was successfully completed.
Additional Manufacturer Narrative
Additional information received: it is reported there was no damage to the cutter and no intervention was required to remove the device.It was reported that there was no patient injury.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the turbohawk was received for evaluation.A detached cutter driver, indicating lot # a338879 was included.No other ancillary devices were included.The cutter driver was visually inspected with no damages or anomalies were noted.The power switch was in the off position.The turbohawk was inspected.Coils were bent & uneven spacing between the coils was observed at the area of bending.No damage to the distal end of the housing segment was noted.The turbohawk was connected to the returned cutter driver.Attempts to advance the thumb switch resulted in it advancing approximately halfway within the slider cover before resistance was experienced.Damage to the laser drilled housing obstructed the cutter from advancing within the housing to complete a packing stroke.A review of the manufacturing records for lot a455926 did not reveal any non-conformity relevant to this reported event.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: 7548152
• Report Number: 2183870-2018-00292
• Device Sequence Number: 13877697
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 05/04/2020
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A455926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 09/20/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/27/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR