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

Catalog Number	TH-LS-M
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the turbohawk device was returned for evaluation.A pair of tweezers was also included with the turbohawk.No other ancillary devices were included.The turbohawk was returned with the cutter assembly retracted within the cutter window.The distal assembly laser drilled coil segment showed a gradual curve throughout the component.Biological debris was noted approximately 1.8cm distal the cutter window.The tweezers was returned with the ends bound together using white tape.Within the prongs of the tweezers was a clear flaked debris.The length of the debris was approximately 0.3cm.The texture of the debris was consistent with rigid texture, not biological.The turbohawk was connected to a cutter driver from the lab.The thumb-switch of the turbohawk was advanced and they cutter assembly advanced approximately 1.8 cm from the cutter window.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a turbohawk directional atherectomy device to treat a moderately calcified lesion in the sfa.The artery was 5-6 mm in diameter.The device was prepped as per the ifu.A 7 french non-medtronic sheath was used and with a "0.014 non-medtronic guidewire.It was reported that after 4 successful passes with the turbohawk device, the physician noticed the device was not showing as full but felt as if it was.The device was inspected, when the device was removed something that looked like a piece of plastic was found in the cutter window.The cutter could not be returned to the housing.A pta balloon and stent were used to complete the procedure.No patient injury was reported.

• Brand Name: ATK TURBOHAWK SMOOTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6881684
• Report Number: 2183870-2017-00411
• Device Sequence Number: 819444
• Product Code: MCW
• UDI-Device Identifier: 00821684065747
• UDI-Public: 00821684065747
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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: 08/12/2019
• Device Catalogue Number: TH-LS-M
• Device Lot Number: A327199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1