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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician used a hawkone device to treat a severely calcified 60mm lesion with 95% stenosis in the right mid common femoral artery, artery diameter 6mm. A 6 f non-medtronic sheath and a 0. 014 guidewire were used. The ifu was followed and vessel was pre-dilated. Moderate resistance was noted during advancement. It was reported that when advancing the hawkone for the last pass, the device jumped forward. The physician then withdrew the device and noticed a failure at catheter and hinge. A technician advanced cleaning tool down to clean and the tip came completely off. Flushing was not performed prior to tip separation. The procedure was completed using a non-medtronic catheter and the vessel was post dilated with a 6/80 in. Pact admiral. No patient injury was reported.
 
Manufacturer Narrative
The device was removed safely from the patient. Following removal, the proximal part of the hinge looked bent. No pieces of the cutter were missing. The patient is doing great and has no issues related to the device failure. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation: visual inspection: the hawkone was removed from the bag and inspected. It was observed the hawkone was returned in two different segments. The distal segment was approximately 7cm of the distal assembly. The housing assembly was fractured off from the unit. The distal segment showed a fracture at the location where the laser drilled coils start at the proximal end. The tecothane layer had smooth edges, however the coil within the tecothane was stretched proximally. A 0. 014" guidewire from the lab was front loaded. It was verified the guidewire tubing was no torn. The proximal segment was returned with the distal flush tool over the distal end. It was observed with the dft, the cutter was visible connected to the driver shaft. Damage to the cutter window housing segment was noted. The dft was removed. It was observed the platinum iridium was crushed and folded in one direction. A radial fracture of the housing assembly was observed. The cutter assembly remained intact connected to the drive shaft. Possible pet from inner housing was noted on the outer rim of the cutter assembly. 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 Key8124186
MDR Text Key129030879
Report Number9612164-2018-03447
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 02/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/09/2021
Device Catalogue NumberH1-M
Device Lot Number0009274193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2018
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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