MAUDE Adverse Event Report: COVIDIEN IRVINE HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-M
Medical Device Problem Codes	Difficult to Flush (1251); Delamination (2904)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hawkone device and a cutter driver were returned.No other ancillary devices were included.The hawkone was inspected and it was noted that the slide cover was detached from the slider cover.A crack to the handle body and flush port was observed.The distal assembly was inspected.The laser drilled coils showed deformation approximately 1.5cm from the cutter window.Possible delamination could be seen.After soaking, the section of the laser drilled coils where the damage was observed was inspected.There was no indication of any holes or tears to the tecothane.The coils were deformed, but no indication tissue had escaped.The distal assembly and flushed.Water was able to exit out the flush mouth; however observed biological debris noted within the laser drilled coils remained.The area of deformation was re- inspected a second time and no holes or abnormalities to the tecothane were found.The slide cover assembly the slider cover were attempted to be re-attached; however due to the crack the unit would not attach as in tended.
Event or Problem Description
The physician was attempting to use a h1-m hawkone to treat a plaque lesion in the distal sfa.The lesion was 200 mm in length with 80% stenosis.The artery diameter was 5 mm with little tortuosity.No abnormalities were reported in relation to the patient¿s anatomy.The device was prepped as per the ifu.A 6 french non-medtronic sheath was used in the procedure and a.014¿ non-medtronic guidewire.No embolic protection was used.Procedural stroke cineradiography images are not available.Pre-dilation of the vessel was not performed.Post-dilation of the vessel was performed.The physician did not meet resistance during advancement.The physician was unable to flush the tissue as tissue was trapped in the nose cone of the device, the physician attempted to flush the driveshaft port and the flush port on the catheter handle broke.The cutter was reported as damaged.In addition, upon cleaning the device it was observed that the nose cone had started to bulge.The cutter was returned into the housing.The physician utilised h1-m hawkone to complete the procedure without further complication.No patient injury was reported.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7052875
• Report Number: 2183870-2017-00521
• Device Sequence Number: 19135408
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A482647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1