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

Catalog Number H1-M

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: a single photographic image was received.The image showed a hawkone cutter assembly with the guidewire lumen zippered from the cutter assembly from its proximal end to approximately the mid-point of the cutter assembly coil.The hawkone h1-m (6fr) was received for evaluation.The hawkone was received with a cutter driver unit, a tweezer, and a 320cm length spiderfx capture wire and filter assembly.The cutter driver unit was functionally tested and performed as expected.The returned cutter exhibited damage - the guidewire lumen on the cutter assembly coil was zippered from the proximal port to approximately the middle of the cutter assembly coil, as seen in the photographic image mentioned.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a hawkone with a spider fx and non-medtronic 6f sheath, to treat a cto in the proximal superficial femoral artery (sfa) and popliteal artery (pa).The device was prepped as per ifu, moderate resistance was encountered during the procedure.It was reported the physician was unable to cross the proximal sfa, pedal access was attempted but unsuccessful.The physician gained access through the thigh and a 4f sheath was placed.The physician crossed the cto retrograde fashion and snared the wire, the popliteal cto was crossed successfully a spider fx was placed proximal to the anterior tibial (at) takeoff.The physician did one pass over the lesion with the hawkone in anterior popliteal (ap) position, after pulling back and rotating 90 degrees a second pass was made, a kink was observed in the spider, during retrieval resistance was encountered.The hawk was pulled back to the sheath, it was observed that the spider had been pulled back to the mid sfa.The physician worked diligently to remove both devices.On removal the wire port was peeled back, and the spider wire was exiting the proximal end of the nosecone near the cutter.Access was regained across the lesion the procedure was completed using a trailblazer, a non-medtronic.014 wire and chocolate balloon.No patient injury reported.

• 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: 8094214
• MDR Text Key: 128040325
• Report Number: 9612164-2018-03295
• 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: Physician
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009286546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• 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: 66 YR
• Patient Weight: 57