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

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.

Manufacturer Narrative

Image analysis:there were seven images returned by the customer.Image 1 shows the coiled device along with a 6fr sheath.The distal section of the balloon is missing.Image 2 shows a 2 way luer adapter.Image 3 shows the 6fr sheath along with a section of the device.There also appears to de a detached section of the inner shaft present.Image 4 appears to show the inflated balloon in the patient¿s vasculature with a twist in the centre of the balloon.Image 5 shows the end of a shelf carton.The label shows the lot number as a980820 and the expiry date as 21st feb 2023.Image 6 shows the device post op, and the distal section of the balloon is missing.Image 7 shows the type of inflation device used in the procedure.Product analysis: the fortrex balloon catheter was received with approximately 25mm of the proximal portion of the balloon and approximately 80mm of detached section of the inner shaft.No functional testing could be carried out due to the condition of the returned device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, 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 Key: 13887486
• MDR Text Key: 293164388
• Report Number: 2183870-2022-00097
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Catalogue Number: A35HPV08040080
• Device Lot Number: A980820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male