MAUDE Adverse Event Report: COVIDIEN HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/06/2018
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
It was reported that the physician used a hawkone m with a 6f 45cm non-medtronic sheath for treatment of a calcified/plaque lesion in the patients right proximal common iliac artery.The vessel was described as slightly calcified and slightly tortuous.The ifu was followed and the hawkone m was prepped without issue.The vessel was not pre-dilated.It was reported that severe resistance was experienced when attempting to withdraw the device.The wire wrapped around the nosecone of the hawkone m.The nosecone became bent resulting in tip detachment.The tip was reported to have separated at the hinge pin.The guidewire was reported to have been torn from the distal tip.Two cut downs were carried out to remove the detached portion.A non-medtronic stent was placed and the procedure was completed.The patient was reported to be stable.
Additional Manufacturer Narrative
Additional information: the nosecone did not completely detach.The two cut downs were performed on both groins to remove the nosecone.The hawkone was not received for evaluation.No ancillary devices from the procedure were received.A single photograph of a cine image was received for evaluation.The cine image shows the cutter housing in the vessel anatomy.The cutter head is not visible in the cutter housing cutter window.The cutter housing does not appear to be separated from the cutter shaft.The cutter housing appears to be separated from the cutter distal assembly coil housing and distal tip.A guidewire appears to run from the cutter housing to the coil housing and distal tip.Based on the cine image the guidewire appears to be prolapsed and the guidewire lumen appears to be zippered.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8128067
• Report Number: 2183870-2018-00561
• Device Sequence Number: 1625424
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• 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,Followup
• Report Date (Section B): 12/17/2018

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: 08/29/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A516437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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