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

Catalog Number	H1-M
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician was treating a lesion in the sfa using a hawkone atherectomy device.The lesion exhibited 90% stenosis and was severely calcified.It was reported that the device was used for several passes.When it was being withdrawn through the proximal sfa the nosecone of the device separated.It was reported that a 6f sheath was replaced by an 8f sheath.Then a 10mm snare was used to remove the tip and spider.The procedure was completed by placing a 0.035¿ wire up and over to the tibial artery.Then the entire sfa was predilated with a 4 x 200 mm evercross balloon.Then distal to the proximal sfa, a 5x150, a 6x150 and a 6x80 inpact admirals were deployed.The final runoff showed open and patent vessel.
Additional Manufacturer Narrative
Device evaluation: the hawk one was received in two segments.The proximal segment attached to a cutter driver with the proximal portion of the laser drilled coil stretched distally.The distal segment included the laser drilled tip, flush mouth, and distal rotating tip.Loaded within the rotating tip of the hawkone was the spider fx.The filter assembly was pulled back to the distal tip of the distal assembly of the hawkone.The blue 6f cook sheath was inspected and noted blood within the valve.The distal tip of the sheath showed a tear approximately 3 mm in length.The cutter driver attached to the hawkone.The thumb-switch was in the forward position.The drive shaft was advanced out of the cutter window with the cutter assembly attached.The proximal end of the fracture face of the laser drilled tip showed the platinum iridium stretched out longitudinally.A spider fx was loaded through the distal assembly.A loop the capture wire was observed approximately 45 cm from the distal tip.The ptfe material of the capture wire was stripped distal of the observed loop.The distal assembly which was fractured distal the cutter window was curved at the distal end.Zipper tearing was noted throughout the guidewire tubing.The coils showed uneven spacing due to the bending of the assembly.Two images were provided by the customer and saw no indication the tip was detached; however improved luminal clearance of the vessel after treatment was noted.The returned devices and damages noted during inspection are consistent with the potential outcome of a prolapse event.If information is provided in the future, a supplemental report will be issued.
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: 6391286
• Report Number: 2183870-2017-00120
• Device Sequence Number: 759701
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2019
• Device Catalogue Number: H1-M
• Device Lot Number: A370738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided; 05/31/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 06/28/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 76