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

Catalog Number H1-LS

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

Patient Problems Injury (2348); Vascular Dissection (3160)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use hawkone atherectomy device to treat a little calcified plaque lesion in the right proximal sfa with 85% stenosis.The vessel diameter and lesion length was 6mm and 80mm respectively.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported that the device broke, separated while trying to remove it from the body.The device had to be removed from the body, and outside of the sheath.A tear occurred at the access site.Protamine had to be given, and a long manual hold was performed.

Manufacturer Narrative

Additional information: it is unknown if the tip detached at the hinge pin.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the tip of the device detached within the vessel but remained on the wire.The device was pulled out along with the sheath from the patient 's body.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the hawkone device was received for evaluation.A guidewire was also returned with the device.No images were received for review.The hawkone device was removed from the return packaging for visual inspection.A radial fracture was noted between the rotating distal tip.The outer diameter of the guidewire was verified by using a snap gauge from the lab; the guidewire outer diameter measured 0.0135¿.The guidewire lumen of the distal housing was noted around the guidewire.A portion of the housing lumen remained attached to the guidewire.The returned guidewire remained loaded through the detached rotating distal tip.The guidewire extended approximately 47.0cm distal to the distal end of the rotating tip.Multiple bends and kinks were noted throughout the guidewire.Bends were also noted at the distal end of the guidewire approximately 0.9cm, 1.3cm, and 2.3cm proximal to the distal tip.It was noted that the coils were separated and stretched at the floppy end of the guidewire.Microscopic examination revealed two loops located along the guidewire, proximal to the hawkone rotating distal tip.At the location of the loop located nearest to the distal rotating tip, the 0.2cm polymide tubing from the hawkone distal housing remained loaded onto the guidewire.Inspection of the guidewire lumen of the rotating distal tip, revealed that the proximal end of the lumen was torn and pulled distally.Further inspection of the guidewire revealed areas where the ptfe was scrapped away.The scraped ptfe suggests exposure to excessive frictional forces.Inspection of the hawkone distal housing revealed biological debris throughout the housing.Multiple bends were observed throughout the housing.Microscopic inspection of the joint connecting the distal housing to the rotating distal tip revealed no anomalies.The guidewire lumen showed disengagement of the guidewire lumen throughout the distal housing.Inspection of the laser drilled inner coils revealed the inner coils were bent inwards at several locations.Inspection of the proximal end of the distal housing revealed that the proximal end of the housing was torn, and the inner coils were exposed.The cutter was returned approximately 1.4cm distal to the cutter window.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: 9070660
• MDR Text Key: 158664753
• Report Number: 9612164-2019-03940
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Catalogue Number: H1-LS
• Device Lot Number: 0009603204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 65