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

Catalog Number H1-LX-INT

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a hawkone for treatment of an extremely calcified lesion.A 7fr sheath and a 7mm spider fx device was used in the procedure.The vessel was not pre-dilated.The ifu was followed.It was reported that the cutter would no longer engage back into the cutter window when the device was switched on.The procedure was completed using another device with no issues.No patient injury was reported.

Manufacturer Narrative

Device evaluation; the device was removed from the return packaging.It was noted the torque shaft was bent at a 90-degree angle.Dried blood and biological material were in the distal assembly.Inspection of the cutter window revealed the drive shaft and cutter were not in the window.Fracture observed, and further inspection revealed the cutter was located approximately 3.0cm distal to the cutter window in the distal assembly.The distal housing was cut to remove the cutter.The cutter measure approximately 1.0cm.It was attached to a portion of the shaft.Inspection of the cutter revealed dents and damage.Examination of the fractured end revealed a coil protruding upward (analysis photo 9).The thumb switch was advanced, and the proximal fracture was observed, the coils appeared twisted.The fractured ends were consistent with a ductile fracture.Image review: one collage image was received, consisting of two cine images.The cine images appear to be before and after cines of the treated targeted vessel.The two photographs appear to be identical and show the debris removed from the targeted lesion.The hawkone was not included in the cine images.The collages show the successful treatment of the lesion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: this incident occurred while testing the device on the table after removing from the patient and cleaning.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7FR
• 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: 8499315
• MDR Text Key: 141459002
• Report Number: 9612164-2019-01262
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: H1-LX-INT
• Device Lot Number: 0009209678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2018
• 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