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

Catalog Number H1-M

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician intended to use a (b)(6) device to treat a moderately calcified 200mm lesion in the mid superficial femoral artery (sfa) with 80% stenosis.The artery diameter was 5mm.Ifu was followed with no issues reported.A non-medtronic 6fr sheath, a 0.014¿ spiderfx guidewire and a 5mm embolic filter were used in the procedure.It was reported that moderate resistant was found upon withdrawal of the device and the entire tip detached at the hinge pin while inside the sheath in the patient.The damaged separated tip and access sheath were removed from the patient.Once the sheath was removed, access was lost and the case could not be completed.No patient injury was reported.

Manufacturer Narrative

Image review: images were returned for evaluation.Image 1 and 2 shows the hawkone device with the distal section being attached.Image 3 shows a detached distal coil housing assembly.The image also reveal a fracture to the coil housing.In the detached location, shows evidence of the tecothane being disengaged and stretching of the coil.No damage was noted to the device distal tip.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: 8102097
• MDR Text Key: 128286064
• Report Number: 9612164-2018-03349
• 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: 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,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009290630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Date Device Manufactured: 08/22/2018
• 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
• Patient Age: 67 YR