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

Model Number	A35HPV08080080
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use fortrex pta during procedure to treat a lesion in the arteriovenous fistula.Inflation device was used.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that during third inflation, balloon burst/leak/catheter leak occurred.It is unknown how the procedure was completed.Patient status is unknown.
Additional Manufacturer Narrative
Additional information: a non-medtronic inflation device was used for balloon inflation.The balloon was placed across a previously deployed stent.The balloon burst.This occurred at 17atm.The rupture occurred in the venous segment of the graft.The balloon was removed by creating a 3mm cut.The sheaths were removed and purse string sutures were used to achieved hemostasis.No vessel damage noted.Patient was discharged in stable condition.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.
Additional Manufacturer Narrative
Device evaluation the fortrex balloon catheter was received with luer detached and balloon detached.A 0.035¿ guidewire from the lab was front loaded via the distal tip and exited out of the detached end of the catheter shaft with no difficulty.Visual inspection shows the balloon detached from the proximal end of the balloon and bunching is seen at the distal end of the balloon.The detachment site on the catheter shaft was measured to be approx.77cm proximal from the distal tip.The luer returned detached at the catheter shaft at approx.2.5cm distal to the end of the strain relief.Microscopic inspection of the balloon shows biologics present and bunching of the balloon.Distal marker band is visible and intact.Proximal marker band visible and intact.Deformation/tear noted on the proximal end of the balloon.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.
Additional Manufacturer Narrative
This report is being submitted as part of a retrospective review and remediation for capa: 564121, per: (b)(4).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.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Common Device Name: 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: 11403567
• Report Number: 2183870-2021-00081
• Device Sequence Number: 14585715
• Product Code: LIT
• UDI-Device Identifier: 00763000106225
• UDI-Public: 00763000106225
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: A35HPV08080080
• Device Catalogue Number: A35HPV08080080
• Device Lot Number: B149614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/03/2021; 04/12/2021; 02/06/2024
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/05/2021; 04/13/2021; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown