MAUDE Adverse Event Report: COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LX
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the returned hawkone device was inspected and noted the cutter assembly was retracted back into the cutter window.No damages or anomalies to the distal assembly were noted.The torque shaft was inspected and found no bends or kinks.Functional testing.The cutter was activated and the thumb-switch could be advanced and retracted back and forth with no resistance; however the cutter assembly remained stationary within the cutter window with no movement.It was discovered the drive shaft was fractured within the slide cover.The fracture face was ductile.
Event or Problem Description
The physician was using a hawkone directional atherectomy device to treat a chronic total occlusion (cto) lesion composed of calcification, fibrous material and plaque in the right mid sfa.The lesion was 200mm in length, the artery was 5 mm in diameter and had no tortuosity.The device was prepped and inserted as per ifu.The sheath used was non-medtronic 7 fr, 45 cm in length.It was reported that after completing three successful passes with the device, it was re-inserted for further cutting after cleaning.It was noted that it sounded different and was not cutting properly.A piece of metal was noted as showing around the trigger and the trigger could not function correctly.The motor would turn on, but the metal would not allow for full engagement of the cutter.There was no damage noted to the distal tip or any issues packing the nosecone.The cutter driver was never separated from the housing.No issues were found inserting the driver into the catheter.The device was removed and another hawk one device was used to complete the procedure.No injury to patient was reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6957252
• Report Number: 2183870-2017-00456
• Device Sequence Number: 795875
• Product Code: MCW
• UDI-Device Identifier: 00821684057933
• UDI-Public: 00821684057933
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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
• Report Date (Section B): 10/17/2017

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: 10/06/2019
• Device Catalogue Number: H1-LX
• Device Lot Number: A355837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1