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

Catalog Number	TH-LX-M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the turbohawk with cutter driver was received for evaluation.The cutter was attached to the returned cutter driver unit for investigation purposes.The cutter was able to spin freely within the cutter window when activated.The cutter head was advanced, and the cutter would stop spinning.The cutter head would not advance its full travel distance distally, (pack).The cutter head was examined; nicks in the cutter head edge were noted.The cutter head would not fully advance into the distal assembly.The profile of the cutter distal assembly indicated several slight bends in the distal assembly.The cutter driver unit was able to perform as intended.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 400 mm soft tissue chronic total occlusion in the sfa.The vessel was reported to have had no tortuosity.The device was prepped as per the ifu with no issues identified.The procedure used a spider filter wire and a 7fr non-medtronic sheath.It was reported that the device jammed and would not close.Two insertions of the device and around 4 passes were made with each insertion when it was noticed that the device not packing.The cutter could not be returned to the housing.The procedure was completed using another turbohawk device.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: 7068023
• Report Number: 2183870-2017-00531
• Device Sequence Number: 903371
• Product Code: MCW
• UDI-Device Identifier: 00821684065754
• UDI-Public: 00821684065754
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/29/2017

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: 09/15/2018
• Device Catalogue Number: TH-LX-M
• Device Lot Number: A160987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1