MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number H1-LS

Device Problems Contamination (1120); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician attempted to use a h1-ls as per the ifu to treat a lesion in the sfa (superficial femoral artery).It was reported the physician performed an initial pass then removed it from the patient.Once reinserted another pass was attempted but there was an issue with it not disengaging all the way where it would not remove any material while running.The device was cleaned again and it was noted by the physician that he saw a "small black piece of something" when inspecting the tip.No patient injury reported.

Manufacturer Narrative

Product analysis: the device was received for evaluation.No ancillary device or images were received.The device was removed from the return packaging for visual inspection.The device was returned detached from the cutter driver.No biological debris was noted within the distal assembly.A slight bend was noted throughout the distal assembly.The bend began approximately 1.0 cm distal to the cutter window and continued toward the distal rotating tip.The distal rotating tip was bent in an ¿s¿ shaped curve.The cutter was returned advanced approximately 2.6cm distal to the cutter window.Microscopic inspection of the rotating distal tip did not reveal a black substance.A 0.014 guidewire from the lab was backloaded through the guidewire lumen to inspect for any debris within the lumen.The guidewire exited the lumen without resistance and a small piece of yellowish debris was observed exiting the lumen.Microscopic examination of the debris revealed it was biological in nature.The cutter driver was then connected to the hawkone and was activated.The cutter could be retracted; however, resistance was encountered.Inspection of the cutter revealed no anomalies.The cutter was then advanced approximately 1.8cm and resistance was encountered.The device was prevented from further advancement due to the observed bends in the distal assembly.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the thumbswtich was able to be turned off.The cutter returned inside the housing for safe removal of the device from the patient.No deformation was noted in the cutter and no pieces were missing.No damage noted to tip.No pet liner delamination reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• 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: 8964204
• MDR Text Key: 156600854
• Report Number: 9612164-2019-03760
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Catalogue Number: H1-LS
• Device Lot Number: 0009664098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1