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 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician used a hawkone device to treat a severely calcified 60mm lesion with 95% stenosis in the right mid common femoral artery, artery diameter 6mm. A 6 f non-medtronic sheath and a 0. 014 guidewire were used. The ifu was followed and vessel was pre-dilated. Moderate resistance was noted during advancement. It was reported that when advancing the hawkone for the last pass, the device jumped forward. The physician then withdrew the device and noticed a failure at catheter and hinge. A technician advanced cleaning tool down to clean and the tip came completely off. Flushing was not performed prior to tip separation. The procedure was completed using a non-medtronic catheter and the vessel was post dilated with a 6/80 in. Pact admiral. No patient injury was reported.

Manufacturer Narrative

The device was removed safely from the patient. Following removal, the proximal part of the hinge looked bent. No pieces of the cutter were missing. The patient is doing great and has no issues related to the device failure. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: visual inspection: the hawkone was removed from the bag and inspected. It was observed the hawkone was returned in two different segments. The distal segment was approximately 7cm of the distal assembly. The housing assembly was fractured off from the unit. The distal segment showed a fracture at the location where the laser drilled coils start at the proximal end. The tecothane layer had smooth edges, however the coil within the tecothane was stretched proximally. A 0. 014" guidewire from the lab was front loaded. It was verified the guidewire tubing was no torn. The proximal segment was returned with the distal flush tool over the distal end. It was observed with the dft, the cutter was visible connected to the driver shaft. Damage to the cutter window housing segment was noted. The dft was removed. It was observed the platinum iridium was crushed and folded in one direction. A radial fracture of the housing assembly was observed. The cutter assembly remained intact connected to the drive shaft. Possible pet from inner housing was noted on the outer rim of the cutter assembly. 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: 8124186
• MDR Text Key: 129030879
• Report Number: 9612164-2018-03447
• Device Sequence Number: 1
• Product Code: MCW
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/09/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009274193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial