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

Catalog Number H1-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use a hawkone h1-s device with a non-medtronic 6fr sheath and 300cm non-medtronic guidewire to treat a 15mm plaque 80% stenotic lesion in the patient¿s mid left anterior tibial artery.The diameter was noted as 2mm.There was slight tortuosity and moderate calcification reported.The ifu was followed during preparation, procedure and post procedure.There was severe resistance in the initial advancement to the lesion and the device was unable to cross the lesion.Follow up angiography showed slower flow in the target lesion.The physician used a 1.5mm euphora pta balloon catheter to treat the lesion.Reduced flow was noted into the foot with embolism and possible spasm in the distal anteriortibial.No patient injury was reported.

Manufacturer Narrative

Additional information: the patient was given nitroglycerin due to the embolism and vessel occlusion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the hawkone was returned.No ancillary devices or cines from the procedure were returned with the device.The hawkone device was removed from the returned packaging and was inspected.Hawkone device was connected to the cutter driver.The torque shaft was bent at an approximate 45-degree angle beneath the strain relief.Inspection of the distal assembly revealed dried blood and biological debris within the distal housing; no anomalies were noted with the guidewire lumen.No fracture was noted throughout the shaft or distal assembly.Cutter was located within the distal housing; dried blood was noted around the drive shaft.A 0.014" guidewire was loaded onto device.The device was inserted into a 6fr sheath without anomalies noted.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: 8599732
• MDR Text Key: 144704001
• Report Number: 9612164-2019-01663
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• 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,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Catalogue Number: H1-S
• Device Lot Number: 0009005038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 105