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

Catalog Number H1-M

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to treat a moderately calcified with 70% stenosis in the right mid sfa to popliteal using hawkone.The vessel is reported to be moderately tortuous.The vessel was post dilated.Ifu was followed.It was reported there was a bulge noticed in the nosecone.It appeared that the jacket was damaged, there appeared to be a bubble of plaque being pushed out of the packing area.There was no damaged to the guidewire lumen.An angioplasty was used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the hawkone device was returned for evaluation.No ancillary device or images were returned with the hawkone.The hawkone device was removed from the packaging for analysis.The hawkone was received with the slide cover inserted into the cutter driver.The rotator assembly was detached with drive shaft assembly exposed.Examination of the cutter driver revealed no anomalies.No cracking of the slide cover was observed.The rotator assembly was able to be reattached to the slide cover.The shaft was bent in an approximate 90-degree angle beneath the strain relief.Inspection of the distal assembly revealed a bulge located 2.1cm distal to the cutter window.The bulge was located on the same plane as the cutter window.The cutter was returned advanced approximately 1.8cm distal to the cutter window.Microscopic inspection of the bulge revealed no tearing to the tecothane coating.Separation and bending of the inner coils was noted.Biological material was noted at the location of the bulge; it was noted that the cutter was proximal to the biological material.Inspection of the distal flush mouth revealed biological material exiting the mouth.Inspection of the debris revealed that it was a hard biological substance.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: 8953455
• MDR Text Key: 156323162
• Report Number: 9612164-2019-03679
• 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,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Catalogue Number: H1-M
• Device Lot Number: 0009773948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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