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

Catalog Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone device with a non-medtronic 6fr sheath and non-medtronic 0.014 guidewire during treatment of a 200mm, calcified, cto (chronic total occlusion-100%) in the patient¿s proximal left superficial femoral artery (sfa) of diameter 6mm.Severe vessel calcification and tortuosity are reported.A tortuous iliac and high bifurcation are also reported.Ifu was followed.No issues reported during preparation of the device.Vessel pre-dilation was not performed.It is reported that moderate resistance was noted during withdrawal of the device resulting in a tip detachment.The tip is reported to have separated at the hinge point proximal to the cutter window.The detached tip was pushed into proximal sfa.The physician then ballooned into the wall of the artery and trapped the detached piece with a medtronic everflex stent.Post-dilation was then performed.No patient injury reported.

Manufacturer Narrative

Image review: three cine images were returned for review.In the first image, it was noted that the patient¿s anatomy had high bifurcation, consistent with the reported event.It was observed that the device appeared to be crossing the lesion.The cutter window of the device was visible at the top of the left iliac artery.Based on the location, the cutter window would be located at the ostium of the left iliac artery.The guidewire was observed in the image and appeared to be running along the vessel and hawkone guidewire lumen.In the second cine image it was observed that the guidewire was no longer running throughout the length of the guidewire lumen of the distal housing.The guidewire appeared to only be tracking through the lumen of the distal rotating tip.It was noted that there was slack in the guidewire and the guidewire was prolapsed near the distal tip of the device.Review of the third cine image revealed a stent within the vessel.The distal tip of a sheath was observed at the top of the cine image.It appeared that the distal tip had detached within vessel and the detached portion of the device was caged by the implanted stent.Due to the quality and clarity of the image the location of the tip detachment could not be determined.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: there was no vessel damage.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: 10050843
• MDR Text Key: 190741521
• Report Number: 9612164-2020-01870
• 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,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 125