MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED

Model Number 6215

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that the balloon appeared intact on checking for inflation under saline in the bowl.The balloon was inserted into the delivery system and forwarded to the coronary sinus position for venogram.The balloon would not maintain inflation when the 3 cc syringe was engaged.The physician tried twice but was unable to get the balloon to perform to standards.A new balloon was requested by the doctor.The balloon catheter was returned to the manufacturer, analyzed and tested out of specification.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter was returned and analyzed.The mechanical operation of the balloon catheter had leaks and/or was incontinent.The mechanical operation of the balloon catheter was occluded.Blood was observed on the shaft of the delivery catheter.The analyst noted the balloon catheter was returned without the inflation syringe.There was dried material on the balloon of the ba lloon catheter.The dried material was removed from the distal end of the balloon catheter to test the inflation of the balloon on the balloon catheter.The balloon was able to inflate and deflate as expected.The balloon lost inflation when the stop cock for the balloon valve was locked to hold inflation from a leak on the balloon valve.There was a leak on the balloon valve at the proximal end while in the inflation hold position on the valve.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

Product event summary: the balloon catheter was returned and analyzed.The mechanical operation of the balloon catheter had leaks and/or was incontinent.The mechanical operation of the balloon catheter was occluded.The balloon catheter handle was cracked.Blood was observed on the shaft of the delivery catheter.Visual analysis of the balloon catheter indicated damage during use.The analyst noted the balloon catheter was returned without the inflation syringe.There was dried material on the balloon of the balloon catheter.The dried material was removed from the distal end of the balloon catheter to test the inflation of the balloon on the balloon catheter.The balloon was able to inflate and deflate as expected.The balloon lost inflation when the stop cock for the balloon valve was locked to hold inflation from a leak on the balloon valve.There was a leak on the balloon valve as the proximal end while in the inflation hold position on the valve.The balloon catheter was sent to the manufacturer who confirmed the complaint with a confirmed leakage in the handle with a crack in the handle that was observed that led to leakage.Correction: h6 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: ATTAIN VENOGRAM BALLOON CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15673402
• MDR Text Key: 306416026
• Report Number: 2182208-2022-03400
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 22C21844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male