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

Catalog Number	H1-M
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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 intended to use a hawkone device with a non-mdt sheath and a non-mdt.014 guidewire for treatment of a 20mm calcified cto (chronic total occlusion-100%) lesion in the patient's mid right superficial femoral artery (sfa) (diameter 6mm).Moderate calcification and slight tortuosity was reported.The ifu was followed.It is reported during the procedure that resistance was felt during advancement of the device and that the tip of the device appeared damaged.The tip did not require retrieval from the patient.Upon removing the device from the patient, the physician noted that tissue had adhered to the side of the nosecone.The procedure was completed as normal and post-dilation was carried out.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the hawkone was returned for evaluation.The hawkone was connected to a cutter driver.No other ancillary devices were included.Visual inspection: the hawkone was visually inspected.A hole through the tecothane was noted which ran parallel with the laser drilled coils.At the hole, red biological debris was observed protruding out.The hole was located approximately 1.5 cm distal to the cutter window and was on the same plane as the cutter window opening (opposite gw tubing).The housing showed bending to the coils distal to the cutter window.The slide cover assembly and the adapter were separated with the drive shaft in-tact.No functional testing was conducted.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: 7573622
• Report Number: 2183870-2018-00312
• Device Sequence Number: 2221507
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/03/2018

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: 06/26/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A482647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 83