MAUDE Adverse Event Report: COVIDIEN IRVINE 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	Patient Problem/Medical Problem (2688)
Date of Event	12/06/2018
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 attempted to use a turbohawk with a spider fx, 8fr sheath and 0.014 guidewire for treatment of a severely calcified plaque lesion with 80-90% stenosis in the patients proximal mid and distal superficial femoral artery and popliteal artery.There were no abnormalities reported in relation to anatomy and moderate tortuosity was reported.Ifu was followed and devices were prepped without issue.The vessel was pre-dilated.After cutting was completed with the turbohawk, the physician attempted to withdraw both devices but resistance was encountered as the spider guidewire was entangled with the turbohawk cutter.Attempts were made for removal but both the spider filer and turbohawk nose cone detached in the vessel and could not be retrieved.The patient was sent for surgery to successfully remove the detached pieces.
Additional Manufacturer Narrative
Device evaluation: the turbohawk directional atherectomy catheter and the spiderfx embolic protection system were received in a large zippered closure plastic pouch, and within a sealed sterilization pouch.No additional ancillary devices were received for evaluation.The turbohawk catheter was received attached to its cutter driver.The cutter driver was removed to allow for easier examination of the cutter distal assembly.All components of the turbohawk catheter distal assembly are accounted for.The distal tip of the turbohawk catheter distal assembly was received loaded on the returned segment of the spiderfx embolic protection system.The turbohawk distal assembly coil was received separated just distal of the cutter window.A segment of tecothane coating remained attached to the cutter assembly just distal of the cutter window.A section of the tecothane coating from the cutter coil was observed tangled up on the cutter head.The turbohawk distal tip and coil section were received loaded on the returned segment of the spiderfx capture wire, filter basket, and floppy distal tip.The spiderfx floppy distal tip coil did not exhibit any abnormality or deformity.The spiderfx filter basket contained procedural biological debris that exhibit some calcified morphology.All distal components of the spiderfx distal assembly are accounted for.The turbohawk coil section separation face exhibits torsional and tensile damage.The spiderfx capture wire exhibits torsional twisting.The torsional twisting indicates that the spiderfx capture wire was twisted around the turbohawk catheter.Approximately 46cm of the spiderfx embolic protection system were received.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: the thumbswitch stopped working while the device was in use in the patient.Film analysis: the atk turbohawk was not returned for evaluation.No ancillary devices or cine images from the procedure were received but two photographic images were provided for evaluation.Both images are of the turbohawk distal assembly and show that the coil section distal of the cutter window has been detached.In the second image the cutter head is visible with what appears to be a polymer wrapped around the cutter head.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 IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8145760
• Report Number: 2183870-2018-00573
• Device Sequence Number: 16619480
• 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): 04/10/2019

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: 04/02/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/01/2019; 04/09/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/28/2019; 04/10/2019
• 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: 60 YR