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	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A turbohawk directional atherectomy device was used for the treatment of a moderately calcified, non-tortuous lesion in left distal superficial femoral artery, which exhibited 80% stenosis.It is reported that the iliac arteries had severe tortuosity.Device was prepped without issue.Ifu was followed.It was reported that there was difficulty in removing the device and the device tip broke because of forced removal from sheath.The tip did remain partially attached to the catheter.The remainder of the procedure was performed without any additional need for further atherectomy using standard balloon angioplasty.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: the turbohawk was returned inserted a cutter driver.The turbohawk was returned with the cutter retracted back into the cutter window.The distal assembly was deformed with various bends throughout the laser drilled coil with biological debris within the inner diameter of the assembly.One of the hinge pins along with the weld was bent proximally.Calcified debris was removed from the cutter window.Damage to the laser drilled coils and one of the hinges was noted.The inability to pull the turbohawk was likely the result of the damage encountered to the tip.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: 6693409
• Report Number: 2183870-2017-00294
• Device Sequence Number: 993072
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: 10/31/2019
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A367934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1