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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number H1-M
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician attempted to use a hawkone to treat a 40mm plaque lesion with 70% stenosis in the mid-right superficial femoral artery. Artery diameter was 5 mm. A non-medtronic 6 fr sheath and guidewire were used. Ifu was followed. No resistance was experienced during advancement. It was reported that flush port was broken and the cutter was damaged. A second device was opened and the same problem was encountered. That device was removed from the patient and balloon angioplasty was performed. No patient injury was reported.
 
Manufacturer Narrative
Additional information: the cutter was inside the housing on removal of the device from the patient. No deformation was noted to the cutter & no pieces were noted to be missing from the cutter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation: visual inspection. It was inspected and found the flush port of the at the base of the unit was intact and shoed no damage. The distal assembly was inspected and found biological debris within the inner diameter of the housing. The flush mouth was inspected and found no damages or anomalies. The cutter was retracted back into the cutter window, traces of a green residue or material was noted around the cutter window. The unknown material would not be from the h1 device. The material/substance is likely related to the procedure and/or from an ancillary device. A bend to the housing assembly was noted approximately 0. 2 cm from the cutter window. Functional testing: the thumb switch was advanced with the cutter driver activated. The cutter was unable to complete a full packing stroke, advanced 1. 5cm distal the cutter window. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameHAWKONE 6FR
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8140996
MDR Text Key129594646
Report Number9612164-2018-03504
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2021
Device Catalogue NumberH1-M
Device Lot Number0009393724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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