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

Catalog Number H1-LX-INT

Device Problem Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); Vascular Dissection (3160)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the dissection was present prior to device use.The cutter was located inside the housing during device removal from the patient and the procedure was completed with another medtronic directional atherectomy device without issue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone device during treatment of a long occlusion with dissection in the patient¿s superficial femoral artery (sfa).It is reported a battery issue occurred and the device stopped working while in use in the patient.The hawkone was removed from the patient and replaced to complete the procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the hawkone device was received into medtronic investigation lab for evaluation along with the cutter driver.There were no ancillary devices or images received.Bend in the torque shaft beneath strain relief? there was bend noted in the torque shaft beneath the strain relief.The slide cover was received inserted into the cutter driver however, the rotator assembly was detached and the drive shaft assembly was exposed.The thumb-switch remained attached and inserted within the cutter driver.A fracture was noted in the rotator collar assembly.A bend was noted in the drive shaft at dislocation area.The drive shaft bend was microscopically inspected and it was noted that the drive shaft was damaged and the inner coil was exposed.No further anomalies were noted with the cutter driver.The cutter driver was returned in the ¿off¿ position.The device was able to be successfully reassembled for functional testing.Biological debris was noted in the distal assembly.Cutter was advanced approximately 2.1cm distal to the cutter window.No damage noted to the distal assembly.The cutter driver was powered on and the cutter was attempted to be retracted within the cutter window however, the cutter driver did not activate during retraction and the cutter was unable to be fully retracted.A functional cutter driver from the lab was connected to the hawkone device and the cutter was retracted successfully.No anomalies were noted with the cutter.The cutter was then advanced.The cutter advanced 2.2cm distal to the cutter window.No anomalies were noted during advancement of the device.Both cutter driver were cracked open and the batteries were inspected.It was noted that the connection on the one of the battery terminals was loose within the reported cutter driver.The battery from the good cutter driver was attached to the returned cutter driver and the hawkone device was connected to the cutter driver.The device was powered on and the cutter was successfully retracted.The bad battery was also connected to the functional cutter driver from the lab and the hawkone was connected however, during retraction the device would not power on.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: 9738440
• MDR Text Key: 182473417
• Report Number: 9612164-2020-00832
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: H1-LX-INT
• Device Lot Number: 0009301733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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: 65 YR
• Patient Weight: 90