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

Catalog Number	THS-LS-C
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
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
Physician used of a turbohawk directional atherectomy device for the treatment of calcified lesion in an unknown vessel.It was reported that during the procedure, the end of catheter separated from the device.The physician retrieved it and tried to remove tissue from the nosecone.When the physician safely tried to re-insert the device again, the end of the catheter was separated.The procedure was then completed with a new turbohawk device of same model.There was no patient impact and the patient was reported as being stable.
Additional Manufacturer Narrative
Evaluation summary the turbohawk was inspected and noted a separation between the torque shaft adapter and the hinge of the laser drilled tip.The turbohawk remained as one unit being held together by the drive shaft and cutter assembly.The platinum iridium was bent at the distal rim of the cutter window.The torque shaft adapter showed indentations where the hinge pins connect to the unit.The hinge was inspected and noted one of the hinge pins was missing.At the location of the missing hinge pin, the laser drilled tip material was bent outwards.Evidence of welding has been identified, three circular arcs around the hole of where the hinge pin inserts has been identified.A visual inspection under the microscope identified the pin perimeter was less likely less than 25% was uncovered.The distal assembly showed damage at the cutter window and the distal assembly separated from the torque shaft.One of the hinge pins from the unit has not been accounted for.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: 6805568
• Report Number: 2183870-2017-00353
• Device Sequence Number: 1541244
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 08/23/2017

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: 08/04/2019
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A322033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1