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

Catalog Number H1-M

Device Problems Defective Component (2292); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician attempted to use a h1-m to treat a lesion in the superficial femoral artery(sfa) as per the ifu.No abnormalities were reported in relation to the patient anatomy.It was reported the thumbswitch on the hawkone device jammed while in use in the patient and would not fully close or open.The device was removed safely from the patient.The device was cleaned but remained stuck.The thumbswitch would not push all the way forward or back, so tissue could not be completely flushed.The customer verified the nosecone was not full.No deformation was noted to the cutter and no pieces of the cutter were reported to be missing the procedure was completed prior to the hawkone thumbswitch malfunction.It was post-dilated with pta.No cine images are available.No patient injury was reported.

Manufacturer Narrative

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

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7669077
• MDR Text Key: 113636405
• Report Number: 9612164-2018-01658
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009076185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 04/10/2018
• 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