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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number H1-LS
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use a hawkone atherectomy device during treatment of a 20cm plaque lesion in the patient¿s mid left superficial femoral artery (sfa). Artery diameter reported as 5mm. No vessel tortuosity or calcification were reported. The device was inspected with no issues noted. The device was prepped per the ifu with no issues identified. Per the scrub using the device in the case, the device was prepped in normal standard fashion with what seemed to be part of the flush valve popping out of place, which was identified prior to use in patient. The device was used properly with the spider fx embolic protection device with a total of three passes made before cleaning. During the cleaning a piece of ¿in-organic¿ material was retrieved from the nose cone itself. The in-organic material is not from patient and has not be identified. It did not appear to be the ptfe liner as it is white in appearance. The spider was not damaged during procedure. The case was completed with another h1-m device without incident. No patient injury reported.
 
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Brand NameHAWKONE 7F
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 Key12049133
MDR Text Key257804824
Report Number9612164-2021-02441
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2022
Device Model NumberH1-LS
Device Catalogue NumberH1-LS
Device Lot Number0009747705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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