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

Catalog Number	H1-M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone was received for analysis.The hawkone was inspected and noted the torque shaft was bent at an approximate 90 degree angle beneath the strain relief.The distal assembly showed the tecothane bulging outward approximately 2 cm distal the cutter window.Tissue appeared to be protruding between the laser drilled coils at the area of the observed bulging.The location of the bulging was on the same plane as the cutter window, opposite of the guidewire tubing.A bulge to the tecothane layer of the distal assembly was observed.Tissue appeared to be protruding.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a hawkone m device with a 6fr ansel cook sheath and 0.014 spartacore guidewire for the treatment of a moderately calcified plaque lesion of length 150 mm which exhibited 60-70% stenosis located in the right mid-distal superficial femoral artery (diameter 4 mm).Device was prepped as per ifu.Once loaded onto the spartacore, physician advanced the catheter into the lesion site and made three cuts resulting in the nosecone filling up.The tissue was unable to be flushed as the bulging on the nosecone would not allow the dft over it.The catheter was safely removed from the patient for cleaning.During cleaning the nose cone, the bulge was observed.The tech tried to advance the dft over the nose cone but had difficulty.A new catheter was opened to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6579908
• Report Number: 2183870-2017-00218
• Device Sequence Number: 13691521
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/21/2017

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: 02/06/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A410450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1