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

Model Number H1-M

Device Problems Difficult to Remove (1528); Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Three photographic images were returned for review.A red blood like substance was noted throughout the returned photographs.The first photograph contained the entirety of a sheath.Due the quality and clarity of the image, the size of the sheath was unable to be determined by the provided photographs.Multiple bends were noted along the shaft of the sheath.A metal, coiled material was noted proximal to the hub of the sheath.The second returned photograph contained a closure view of the sheath shaft.Multiple bends and kinks were noted along the shaft.It appeared that the sheath may have torn; however, the tear could not be confirmed due to the quality and clarity of the image.The third returned image contained the sheath hub.A coiled, mental material was observed exiting the proximal end of the hub.The material was consistent with the inner coils of the sheath.It is possible that the inner coils were removed during removal of the hawkone device.The hawkone device was not visible within the returned photographs.The returned photographs were consistent with the reported event.Product analysis: the hawkone device was returned within a (b)(6) package.No ancillary devices were returned with the device.The slide cover was inserted into the cutter driver; however, the rotator assembly was detached with the drive shaft exposed.A bend was noted in the drive shaft.A fracture was noted in the rotator assembly collar.The rotator assembly and slide cover were able to be successfully reassembled.A bend was noted in the torque shaft beneath the strain relief.Biological debris was noted in the distal assembly.Multiple bends were noted throughout the distal assembly.A kink was noted in the distal housing approximately 2.8cm distal to the cutter window assembly.It was noted that the inner laser drilled coils were also bent and separated throughout the housing.The cutter was advanced was advanced ap proximately 2.5cm distal to the cutter window.Microscopic inspection revealed no anomalies with the cutter window.The distal housing revealed multiple locations where the inner laser drilled coils were bent and separated.It was noted that the tecothane coating was torn in four different locations along the housing assembly.Tearing of the tecothane occurred where the inner coils were bent and separated.Zipper tearing at rotating distal tip guidewire lumen.Guidewire lumen of the distal housing remained intact; however, bending and biological debris was noted.A 0.014¿ guidewire was inserted into the guidewire lumen of the distal housing and rotating distal tip.Resistance was noted during insertion due to the bends within the distal housing.The hawkone and guidewire were then advanced through a 6fr sheath.No anomalies were noted during advancement of the device through the sheath.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a hawkone device during treatment of a calcified lesion in the patient¿s proximal common iliac artery (cia) <(>&<)> superficial femoral artery (sfa).Moderate vessel calcification and tortuosity are reported.There was no damage noted or seen when prepping the hawkone device.The device was prepped per the ifu.Vessel pre-dilation was not performed.The hawkone could not go up and over the bifurcation through a 6fr non-medtronic sheath as severe resistance was noted during initial advancement, and the device appeared stuck in the sheath.There was much difficulty when pulling the hawk out of the sheath.A 7fr sheath was then inserted and was advanced after dilation of the lesion in the iliac.A replacement hawkone device was then easily advanced through the sheath to treat the sfa lesion.No patient injury reported.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10037520
• MDR Text Key: 192194178
• Report Number: 9612164-2020-01812
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009922799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• 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 Weight: 70