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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-LX-INT
Device Problem Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); Vascular Dissection (3160)
Event Date 01/23/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the dissection was present prior to device use. The cutter was located inside the housing during device removal from the patient and the procedure was completed with another medtronic directional atherectomy device without issue. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a hawkone device during treatment of a long occlusion with dissection in the patient¿s superficial femoral artery (sfa). It is reported a battery issue occurred and the device stopped working while in use in the patient. The hawkone was removed from the patient and replaced to complete the procedure. No patient injury reported.
 
Manufacturer Narrative
Product analysis: the hawkone device was received into medtronic investigation lab for evaluation along with the cutter driver. There were no ancillary devices or images received. Bend in the torque shaft beneath strain relief? there was bend noted in the torque shaft beneath the strain relief. The slide cover was received inserted into the cutter driver however, the rotator assembly was detached and the drive shaft assembly was exposed. The thumb-switch remained attached and inserted within the cutter driver. A fracture was noted in the rotator collar assembly. A bend was noted in the drive shaft at dislocation area. The drive shaft bend was microscopically inspected and it was noted that the drive shaft was damaged and the inner coil was exposed. No further anomalies were noted with the cutter driver. The cutter driver was returned in the ¿off¿ position. The device was able to be successfully reassembled for functional testing. Biological debris was noted in the distal assembly. Cutter was advanced approximately 2. 1cm distal to the cutter window. No damage noted to the distal assembly. The cutter driver was powered on and the cutter was attempted to be retracted within the cutter window however, the cutter driver did not activate during retraction and the cutter was unable to be fully retracted. A functional cutter driver from the lab was connected to the hawkone device and the cutter was retracted successfully. No anomalies were noted with the cutter. The cutter was then advanced. The cutter advanced 2. 2cm distal to the cutter window. No anomalies were noted during advancement of the device. Both cutter driver were cracked open and the batteries were inspected. It was noted that the connection on the one of the battery terminals was loose within the reported cutter driver. The battery from the good cutter driver was attached to the returned cutter driver and the hawkone device was connected to the cutter driver. The device was powered on and the cutter was successfully retracted. The bad battery was also connected to the functional cutter driver from the lab and the hawkone was connected however, during retraction the device would not power on. 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 Key9738440
MDR Text Key182473417
Report Number9612164-2020-00832
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Catalogue NumberH1-LX-INT
Device Lot Number0009301733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
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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