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

Catalog Number	THS-SX-C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Embolism (1829); Patient Problem/Medical Problem (2688)
Date of Event	03/07/2018
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
The patient has a history of pad, renal failure.The physician intended to use the turbohawk and spider fx 5 mm and 6¿fr biotronik sheath to treat a severely calcified lesion, with 95-99% stenosis in the mid superficial femoral artery as per ifu.It was reported that severe calcification noted throughout the iliac, femoral and tibial vessels.The target lesions were crossed and predilated.The spider was placed in the distal popliteal artery.After pre-dilation the turbohawk was difficult to pass through and rotate, multiple passes were completed.Severe resistance was encountered removing the turbohawk, after fluoroscopic inspection it was observed that the wire was wrapped around the turbohawk.Numerous kinks were observed in the wire, attempts were made to untangle the wire from the turbohawk.The device and sheath were pulled back with resistance across aortic bifurcation, as a result the turbohawk nosecone separated at the hinge point from the catheter shaft in the common iliac artery.The spider wire did not fracture, the basket was in the proximal right sfa.Left sheath access was maintained the patient was transferred to hospital for a right femoral cutdown to retrieve the spider and nosecone.The or procedure was successful in removing the spider and nosecone of the turbohawk, with no complications reported.
Additional Manufacturer Narrative
The turbohawk btk directional atherectomy catheter was received for evaluation but the distal assembly and guidewire lumen were not included.No ancillary devices were received.A disc containing 12 dicom images folders was received for evaluation.The images are of the patient¿s right leg.Film analysis: evaluation of the film analysis showed contrast flow through the right common iliac artery, right femoral artery and right tibial artery.No component of the turbohawk, or ancillary devices were observed in the image of the right common iliac artery.In one image of the right tibial artery a guidewire navigated the full length of vessel is visible.In the images of the right femoral artery, signs of severe calcification in the mid superficial femoral artery were observed and a guidewire being navigated through the calcified vessel was also visible.One image showed treatment of the right femoral artery with a pta balloon.Device analysis: the device exhibited a tearing of the distal assembly just distal of the cutter window.The separation face exhibited torsional damage just distal of the cutter window and the distal edge of the cutter window exhibited signs of a cutter crash.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BTK TURBOHAWK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7398771
• Report Number: 2183870-2018-00206
• Device Sequence Number: 1325496
• Product Code: MCW
• UDI-Device Identifier: 00821684065853
• UDI-Public: 00821684065853
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103618
• 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): 05/03/2018

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: 12/20/2019
• Device Catalogue Number: THS-SX-C
• Device Lot Number: A392626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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: 84 YR
• Patient Weight: 82