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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number A35HPV08040080
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Event Date 03/17/2022
Event Type  Injury  
Event Description
Physician was attempting to use the fortrex pta balloon during procedure to treat fibrous lesion in the left brachiocephalic fistula (bcf). There was no calcification or tortuosity. There was bcf stenosis. A non-medtronic 6fr sheath and guidewire were used. The balloon was inflated with a medtronic everest 30 inflation device. Contrast inflation fluid was used. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. It was reported that a circumferential/radial balloon burst occurred during balloon inflation at 20 rbp followed by 24-26 atm. At least 3 inflations were applied to the device prior to the issue occurring. The device or component detached, cracked, or fractured during device removal from patient body through sheath. There was shaft stretching. Excessive force was used during withdrawal. The fortrex was unable to open the lesion that was causing wasting of the balloon. An attempt to massage (using finger to compress on the balloon) the lesion with balloon expanded inside the vessel was done for a few times, timed 1-2 minutes each attempt. The pressure used for these attempts ranged from 20-26 atm. Patient complained of pain with inflation of balloon. The fortrex balloon ruptured beyond rbp. One radiopaque marker was found dislodged and retrieved outside patient body, together with balloon catheter that has 3cm of balloon material intact. There is another broken portion of balloon catheter that is elongated due to forcefully pulling it out from the sheath. Physician was unable to confirm if all balloon material was removed from patient and if the broken blue catheter is the remaining part of the distal balloon catheter. Another radiopaque marker could not be found. The patient was sent to recovery bay and brought back in to the angio room to locate the missing radiopaque marker. Patient was very unhappy and worried. The chest, neck and head were scanned with angio machine at multiple random angles to try and locate the radiopaque marker. The radiopaque marker outside patient body was used as reference for fast identification. Physician wonders where is the remaining 10mm of balloon material that is missing. Physician suspected the remnants to be inside patient body because the retrieved device is 30mm long balloon material intact to balloon catheter. Physician's immediate concern was the dislodged material will travel to the lungs. The complication associated with the event included that the patient received additional radiation in the effort to locate the missing half of the broken fortrex balloon. The procedure was completed with non-medtronic 8mm x 60mm balloon and non-medtronic inflation device. Currently there is no intervention planned to remove foreign body because during the procedure day itself, the foreign body could not be located. No vessel damage noted. No further patient injury reported. Per follow up with the doctor the next day, on how the patient is doing, he responded positively saying the patient is ok.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameFORTREX 0.035 OTW PTA BALLOON CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13887486
MDR Text Key293164388
Report Number2183870-2022-00097
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA35HPV08040080
Device Lot NumberA980820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
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