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

Catalog Number	H1-S
Medical Device Problem Codes	Kinked (1339); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a hawkone device to treat a 100 mm, severely calcified, cto (chronic total occlusion-100%) in the mid left anterior tibial artery.The vessel had a diameter of 2.5 mm and had little tortuosity.The procedure used a non-medtronic 6 fr 90 cm sheath and a non-medtronic 300 cm guidewire along with the hawkone device.The vessel was pre and post dilated.The device was prepped as per the ifu with no issues identified.As the catheter was being removed it became difficult to withdraw it through the sheath due to severe resistance.It was reported that the nosecone became separated and lodged in the sheath.A kink was found in the mid to distal wire after the sheath was removed.A new sheath was inserted and access re-established.Pta was performed.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis returned contents.The hawkone was returned connected to a cutter driver.Ancillary devices included: non-medtronic introducer 6f and a non-medtronic 0.014" guidewire.No other ancillary devices were included.Visual inspection: the non-medtronic 6f introducer was inspected.It was discovered at the distal rim of the sheath, the material was pinched inward.No other damages to the sheath or the sheath components (hemostat valve and dilator) were observed.The non-medtronic 0.014" guidewire was inspected.The guidewire was bent at 57cm and 59 cm from the distal tip.At the bend 57cm from the tip, the outer coating was stripped away showing a copper appearance beneath the gray external coating.The hawkone was inspected and the distal assembly was observed to be fractured apart.Approximately 5.5cm of the distal assembly fractured off from the hawkone.The fracture face showed the laser drilled coils bent/deformed outwards (ductile fracture).The guidewire tubing of the distal assembly showed zipper tearing throughout the laser drilled coil segment.No zipper tearing was noted to the distal rotating tip.The proximal segment of the hawkone device was inspected.The drive shaft was exposed with the cutter assembly attached at the distal end.Approximately 2cm of the drive shaft was exposed out from the cutter window location.The fracture face was approximately 0.2cm from the cutter window.The fracture face was distal of the vent holes and proximal to the proximal end of the guidewire tubing.The fracture occurred at the location of the proximal end of the guidewire tubing of the distal assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7128063
• Report Number: 2183870-2017-00599
• Device Sequence Number: 2037479
• Product Code: MCW
• UDI-Device Identifier: 00643169792319
• UDI-Public: 00643169792319
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 03/06/2018

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: 06/14/2020
• Device Catalogue Number: H1-S
• Device Lot Number: A475999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65