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

Catalog Number	H1-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
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
The physician was attempting to use a hawkone directional atherectomy catheter to treat a 20mm severely calcified lesion (90% stenosis) in the proximal right sfa.The vessel had little tortuosity and a 7mm diameter.The device was prepped as per the ifu with no issues identified.The procedure used a 6fr 70cm non-medtronic sheath and a 7mm spider.014¿ filter wire.The vessel was pre-dilated but was not post-dilated.The guidewire was hydrated at preparation.The device was advanced over bifurcation.Severe resistance was experienced during withdrawal and wire wrap around the catheter occurred.This caused the wire to loop during attempted removal of the device from the patient and the device locked up on the wire.The device tip broke off inside the sheath but the device and tip were removed with the sheath.The spider wire remained inside the patient as the only access to vessel.The physician cut the 0.014" spider wire outside the patient to prevent the wire from being pulled out through the groin access site.The physician then attempted to pass a new 10cm 5fr non-medtronic micropuncture sheath over the spider wire into the common femoral artery at the access site but this was unsuccessful.Percutaneous access on opposite groin was successful and a wire, catheter, sheath and snare were used to retrieve the spider filter /wire.Manual pressure was held at the initial groin access site (left), and eventual closure on opposite groin (right) was achieved but the procedure was unable to be completed.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7323818
• Report Number: 2183870-2018-00132
• Device Sequence Number: 11164085
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/08/2018

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: 03/08/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A426455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR