MAUDE Adverse Event Report: COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician intended to use a hawkone device for treatment of an unknown vessel.Device was prepped as per ifu without issue.It is reported there was a break during the procedure.Awaiting follow-up information.No patient injury reported.
Additional Manufacturer Narrative
Additional information received: the physician indicated that the device was over packed.No further information is available.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The hawkone was received for evaluation.No ancillary devices or cine images from the procedure were received.The hawkone was received with the cutter driver still attached to the catheter.The cutter driver was functionally tested and it was able to energize.The cutter driver was removed from the catheter to allow easier examination of the catheter.The distal assembly of the catheter was examined and a bulge in the tecothane was noted just proximal to the distal flushing port.The bulge in the tecothane exhibited a rupture of the tecothane coating located approximately 26mm proximal the distal assembly distal tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7234474
• Report Number: 2183870-2018-00052
• Device Sequence Number: 19119117
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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,Followup
• Report Date (Section B): 04/11/2018

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: 03/01/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A235789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 02/15/2018; 03/13/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/13/2018; 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1