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

Catalog Number	H1-M
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2017
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 employed the use of a hawkone atherectomy device with a non-medtronic 6fr sheath, an unknown make of a.014¿ gw and a 6mm spider fx embolic protection device for treatment of a severely calcified 80mm cto lesion in the distal sfa/popliteal artery.The ifu was followed.The vessel was pre-dilated.It was reported that resistance was severe during withdrawal of the device which resulted in a tip detachment.The spider fx did not detach but instead had two loops that caused the wire to kink which would not let the hawkone past and was holding the nose cone from being removed.The nose cone of the hawkone was stripped off the device.The guidewire lumen was torn from the distal tip.The guidewire did not lock-up on the catheter.The patient was taken to the operating room(or) and a cutdown at the femoral head was performed to remove the detached nose cone and the spider fx device.The spider fx was removed at the same time as the nose cone as the wire was directly through the centre.It was reported that the patient is recovering well from the open procedure.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7128220
• Report Number: 2183870-2017-00597
• Device Sequence Number: 13805583
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 12/19/2017

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: 08/09/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A505979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/19/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 93