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

Catalog Number H1-M

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7128220
• MDR Text Key: 95232309
• Report Number: 2183870-2017-00597
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A505979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Date Device Manufactured: 08/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 93