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

Catalog Number	THS-LS-C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a turbohawk device with a spider fx embolic protection device during treatment of a 70mm, 90% stenosed moderately calcified lesion in the patient¿s mid superficial femoral artery (sfa) of diameter 5mm.Vessel described as being non-tortuous.Ifu was followed and the device was prepped without issue.The vessel was pre-dilated.It is reported during withdrawal of the device following second advancement, severe resistance was felt, and the tip separated at the hinge pin.The tip is reported to have embolised at the target lesion.It has been reported the tip was ¿pulled out of the body normally¿.A vessel dissection was also reported.The device was replaced and the procedure was completed.
Additional Manufacturer Narrative
Additional information: while the detachment occurred during the procedure, no portion detached in the patients and was observed fol lowing removal of the device from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: email address product analysis the turbohawk was returned inside a clear bio-hazard bag with a tweezers and a distal flush tool.No ancillary devices were received.During visual inspection it was noted that the cutter blank was visible within the cutter window and that the platinum iridium of the distal rim of the cutter window was bent/curved outwards.The platinum iridium of the housing was bent and was shifted to the side.The housing was not aligned with the proximal area of the cutter window.Functional testing was performed.The thumb switch was retracted and the cutter pulled back to the proximal end of the cutter window as intended.The thumb switch was advanced, however the turbohawk could not complete a packing stroke.The rim of the cutter could not pass through the cutter window as the rim of the cutter was making contact with the bent portion of the platinum iridium.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
• MDR Report Key: 8099791
• Report Number: 2183870-2018-00527
• Device Sequence Number: 1833809
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A488656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 02/14/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 02/11/2019; 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR