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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
Model Number H1-M
Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the hawkone device was received loosely in a double sealed biohazard bag within a safe pack biohazard tyvek pouch. The lot number was verified on the outer product label and confirmed as 0010386420. Device returned with detached tip assembly and device connected to the cutter driver. Visual inspection confirms that the detachment site occurred distal to the anchor pockets with the cutter visible at the end of the drive shaft. No anomalies noted with the cutter. Device returned with thumbswitch in off position and the power switched on. Detachment site visible distal to the anchor pockets and the cutter attached to the drive shaft. Detachment site visible at the proximal end of the tip assembly with bunching and deformation noted to the guidewire lumen at the proximal end. A 0. 014¿ guidewire from the lab was unable to be loaded via the distal to due to biologics present. After soaking the tip assembly in a water bath for a few hours the guidewire was then able to be loaded without issues. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a hawkone atherectomy device with a non-medtronic 6fr sheath and non-medtronic 0. 014 guidewire during trea tment of a 5cm calcified lesion in the patient¿s distal right popliteal artery and tibial/popliteal trunk. Artery diameter reported as 5mm. Moderate vessel tortuosity and severe calcification reported. Lesion exhibited 80% stenosis. Ifu was followed. The device was advanced over the bifurcation. It is reported the tip of the device was damaged during the procedure. The guidewire lumen was reported to be torn from the distal tip. The guidewire did not lock-up on the catheter. It is reported everything was safely removed from the patient and access point was closed. New access was gained on antegrade side to complete the procedure. No patient injury reported.
 
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Brand NameHAWKONE 6FR
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11524114
MDR Text Key242669415
Report Number9612164-2021-01037
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
Report Date 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010386420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2020
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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