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

Model Number A35HPV08040080

Device Problem Burst Container or Vessel (1074)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a fortrex pta balloon during procedure to treat a lesion in left distal of an unknown vessel with 75%.The vessel diameter and lesion length are 8mm and 40mm respectively.The vessel was little tortuous.There was no damage to device packaging.There was no issue removing device from hoop/tray.The device was prepped per ifu with no issues identified.The device did not pass through a previously-deployed stent.There was no resistance encountered when advancing the device.Excessive force was not used.It was reported that during first balloon inflation, circumferential/radial burst at 20 atm occurred.All fragments of the balloon was not retrieved.Perm cath was implanted after patient dialysis graft shut down.Dialysis graft shut down with a portion of the fortrex remaining inside the patient.Perm cath was implanted as a result.No further patient injury reported.

Manufacturer Narrative

Additional information: negative prep was performed.Normal saline and contrast was used as inflation fluid.The vessel was predilated.The balloon rupture occluded the fistula.There are no plans to remove the balloon fragments that remain within the patient.The patient is currently well.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.

Manufacturer Narrative

Device evaluation visual inspection: the fortrex was removed from the protective hoop and pieces of the catheter placed inside a specimen container were inspected.The three pieces of the catheter placed inside the container were inspected.The first segment measured approximately 1.8cm long, the second segment was approximately 3cm and the third segment was approximately 2.3cm.Each segment showed ductile or torsional fracture face.The catheter material showed twisting and evidence of encountered excessive tensile forces.It is possible portions of the catheter were cut using a sharp instrument.The proximal catheter segment was inspected.The manifold assembly indicated 08x40mm, which is consistent with the product labeling associated to lot b054194.The distal end of this segment showed approximately 2cm of the balloon remained attached.A radial burst of the balloon was observed at the distal end.The working length of the blue catheter shaft up to the proximal end of the balloon was approximately 73cm.The distal end of the balloon or marker bands from the catheter were not included with the returned contents.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, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10520316
• MDR Text Key: 206506221
• Report Number: 2183870-2020-00291
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000106195
• UDI-Public: 00763000106195
• Combination Product (y/n): N
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: A35HPV08040080
• Device Catalogue Number: A35HPV08040080
• Device Lot Number: B054194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR