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

Catalog Number H1-M

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician attempted to use a hawkone to treat a 40mm plaque lesion with 70% stenosis in the mid-right superficial femoral artery.Artery diameter was 5 mm.A non-medtronic 6 fr sheath and guidewire were used.Ifu was followed.No resistance was experienced during advancement.It was reported that flush port was broken and the cutter was damaged.A second device was opened and the same problem was encountered.That device was removed from the patient and balloon angioplasty was performed.No patient injury was reported.

Manufacturer Narrative

Additional information: the cutter was inside the housing on removal of the device from the patient.No deformation was noted to the cutter & no pieces were noted to be missing from the cutter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: visual inspection.It was inspected and found the flush port of the at the base of the unit was intact and shoed no damage.The distal assembly was inspected and found biological debris within the inner diameter of the housing.The flush mouth was inspected and found no damages or anomalies.The cutter was retracted back into the cutter window, traces of a green residue or material was noted around the cutter window.The unknown material would not be from the device.The material/substance is likely related to the procedure and/or from an ancillary device.A bend to the housing assembly was noted approximately 0.4 cm from the cutter window.Functional testing: the thumb switch was retracted and advanced with the cutter driver activated.The cutter was able to complete a full packing stroke, advanced 2.3cm distal the cutter window.If information is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: 8141009
• MDR Text Key: 129594310
• Report Number: 9612164-2018-03505
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009399678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 12/12/2018; 02/21/2019
• Supplement Dates FDA Received: 12/17/2018; 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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