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

Catalog Number	THS-LS-C
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use a turbohawk directional atheterctomy device to treat a severely calcified lesion in the mid right sfa.The artery was 6 mm.No abnormalities were reported in relation to the patient¿s anatomy.The device was prepped with no issues identified.Patient had received versed and fentanyl for conscious sedation.It was reported that after successfully performing the atheterctomy procedure, it was noted that the trigger on the device would not close.While moving the device and holding pressure on the trigger, "an audible pop" was heard and felt on the device while the distal end of the catheter was in the sheath.The cutter and the nosecone were both dislodged from the main catheter with the cutter being stuck in the cutter window.It was discovered the nosecone was detached after removal from the patient.An unknown stent was reported to be deployed in the lesion after atheterctomy, followed by a post-dilation using a 6mm unknown balloon.The procedure was successfully completed and no patient injury was repor ted.
Additional Manufacturer Narrative
Device evaluation summary: the turbohawk directional atherectomy device was received for evaluation.The turbohawk was received with the cutter driver unit attached and the distal assembly separated at the hinge.All components of the cutter were accounted for.The hinge pins remain attached to the distal assembly.One of the hinge pins is bent proximal.The proximal bending of the hinge is indicative of excessive tensile force being applied to the distal assembly.There is no evidence of hinge pin weld gap anomaly or void in hinge pin weld.A disk of cines from the procedure were received and reviewed.The disk contained 17 folders.The first folder examined contained 29 cine images from the procedure.The sixteen other folders contained short cine series from the procedure.In none of the images provided is the turbohawk direction atherectomy device.The images confirm significant debulking of the lesions was performed and that a stent was implanted.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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6943121
• Report Number: 2183870-2017-00440
• Device Sequence Number: 705338
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111723
• 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,Followup
• Report Date (Section B): 11/30/2017

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: 04/24/2020
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A450054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 95