MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone device was returned for analysis.The hawkone device was returned inserted the cutter driver.The cutter driver was not powered on and the cutter assemble was retracted back into the cutter window.The distal assembly was inspected and observed the laser drilled tip was damaged.The top distal rim of the cutter window was penetrated and was tore approximately 4mm.The platinum iridium of the rim of the distal assembly was not located, it is unknown if a piece may have sheared off.Dried blood was noted behind the cutter and torque shaft of the unit.Functional testing: the cutter driver was powered on and could not advance the cutter out of the cutter window.Verified the cutter was rotating.Four images were also received for analysis.Images 577, 578, and 579 show a stent implanted in the vessel.Tantalum markers have been identified on the ends of the stent.The images show restricted blood flow throughout the vessel the stent has been implanted.Image 580 shows less restriction and apparent improved blood flow within the stent and outside of the stent for the treated vessel.No images of the spider fx or hawkone were able to be identified within the vessel.
Event or Problem Description
Physician employed the use of a hawkone directional atherectomy device with a 7fr 45cm non-medtronic sheath and a 6mm spider fx embolic protection device for treatment of an in-stent restenosis (isr) in the mid/proximal superficial femoral artery (sfa).Plaque lesion exhibited 90% stenosis.It was reported that there was damage noted to the cutter during the procedure.No stent interaction was noted.Stent was still in place.Thumb switch would not advance cutter into nosecone properly.No damaged component needed to be retrieved from the patient.The cutter was half outside the housing for removal of device from the patient.Follow up angioplasty with drug-coated balloon (dcb) was performed to complete the procedure.No patient injury reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6789487
• Report Number: 2183870-2017-00345
• Device Sequence Number: 129491
• Product Code: MCW
• UDI-Device Identifier: 00821684057933
• UDI-Public: 00821684057933
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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): 07/14/2017

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: 07/14/2019
• Device Catalogue Number: H1-LX
• Device Lot Number: A310551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 87