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

Catalog Number	H1-LS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the hawkone was returned for evaluation.The hawkone was connected to a cutter driver.No other ancillary devices were included.The hawkone was removed from the packaging and inspected.It was observed the torque shaft was bent at the distal edge of the strain relief.The bend of the torque shaft was quite flexible.The cutter was located within the cutter window with biological debris noted around the cutter and cutter window of the distal assembly.The hypotube was observed protruding out from the slider cover.The hypotube was bent up and out from the slider cover and then back down again.A tweezers was used to pull the distal portion of the hypotube out from the slider cover.It was discovered the hypotube and drive shaft had fractured.The fracture face of the drive shaft and hypotube was ductile.The distal assembly showed the cutter assembly retracted back into the cutter window.No damages to the housing assembly were noted.Biological residue was observed within the cutter window.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a hawkone ls to treat a moderately calcified lesion with 70% stenosis in the mid right superficial femoral artery(sfa).Artery diameter and lesion length were reported as 7mm and 80mm, respectively.Physician used a non-medtronic 7fr sheath and a 0.014 spider filter.The ifu was followed and the device was prepped without issue.It was reported that the thumb switch malfunctioned with spring like protrusion seen in front of thumb switch.The physician made 2 passes; device was cleaned and reinserted.Upon attempting to turn device on to continue atherectomy, the thumb switch wouldn¿t move and an object was protruding in front of thumb switch at the base was seen.The catheter did not experience difficulty locking into or releasing from the cutter driver.The thumb-switch was held forward but it is unknown if the blade returned fully to the housing for removal from the patient.The procedure was completed using a new hawkone ls.No patient injury 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: 8098633
• Report Number: 2183870-2018-00520
• Device Sequence Number: 11304001
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/22/2018

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: 06/29/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A303101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR