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

Catalog Number	H1-S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone was received for evaluation.The hawkone was received with a spiderfx loaded within the distal tip of the cutter assembly.The guidewire lumen on the cutter has been zippered by the spiderfx capture wire.The spiderfx capture remains in the distal tip of the cutter guidewire lumen.A kink in the distal window of the cutter was noted.The damage to the h1 cutter is consistent with the spiderfx capture wire being prolapse before the proximal end port of the cutter was drawn into the support sheath.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 treat patient at the distal superficial femoral artery and popliteal artery using a hawkone directional artherectomy device and spider embolic protection device.Vessel was pre and post-dilated.Device was advanced over a bifurcation.It is reported that hawkone device was unable to cross the lesion due to severe resistance.Severe resistance was also experienced when attempting to withdraw.It is reported that guidewire lumen was torn from the distal tip and allowed the 0.014" guidewire to protrude.Spider wire then locked up around the nosecone.System was removed in tandem.Procedure was completed by advancing a 0.035" guidewire to tibial and stenting/pta was performed.No patient injury reported.When device was returned for analysis it was noted the guidewire lumen had been zippered by the spider.
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 (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6645908
• Report Number: 2183870-2017-00262
• Device Sequence Number: 966533
• Product Code: MCW
• UDI-Device Identifier: 00643169728783
• UDI-Public: 00643169728783
• 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,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2017

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: 10/10/2017
• Device Catalogue Number: H1-S
• Device Lot Number: A346311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR