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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 Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Patient Problem Vascular Dissection (3160)
Event Date 12/10/2021
Event Type  Injury  
Event Description
Physician was attempting to use a hawkone atherectomy device to treat a little tortuous, little calcified, plaque lesion within the mid superficial femoral artery. Device prepped per ifu with no issues identified. It was reported that device was caught on a stent strut and was pinched. Device wouldn't come free so they called rep who talked them through getting the device free from the stent. Nosecone separated from catheter. No intervention was required for tip removal. It was trapped by the spider and removed with the sheath. The stent was damaged. Pieces of the stent were inside the nose cone. The vessel had a small dissection. The procedure was completed by accessing ipsilateral and placing another stent. No other complications were reported. There was no damage to the spiderfx device and the damaged stent was not a medtronic stent. No patient injury reported.
 
Manufacturer Narrative
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 was attempting to use a hawkone atherectomy device to treat a little tortuous, little calcified, plaque lesion within the mid superficial femoral artery. Device prepped per ifu with no issues identified. It was reported that device was caught on a stent strut and was pinched. Device wouldn't come free so they called rep who talked them through getting the device free from the stent. Nosecone separated from catheter. No intervention was required for tip removal. It was trapped by the spider and removed with the sheath. The stent was damaged. Pieces of the stent were inside the nose cone. The vessel had a small dissection. The procedure was completed by accessing ipsilateral and placing another stent. No other complications were reported. There was no damage to the spiderfx device and the damaged stent was not a medtronic stent. 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 Key13167189
MDR Text Key286114623
Report Number9612164-2022-00032
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-LS
Device Catalogue NumberH1-LS
Device Lot Number0010619806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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