MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number 2ACH20

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

Product id: afapro28, product type: balloon catheter.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.

Event Description

It was reported that during a cryo ablation procedure, it was difficult accessing and occluding the right superior pulmonary vein (rspv).It was then reported that the mapping catheter became stuck in the entrance of the balloon catheter.It was then reported that an unknown system notice was received indicating an issue with the balloon integrity.The catheters were removed and the case was aborted while the patient was under general anesthesia. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 2ach20 mapping catheter with lot number 8468089 was returned and analyzed.Visual inspection of the loop segment area of the mapping catheter showed the loop was pinched between electrode seven and eight.The pebax segment area showed the tubing was ribbed at approximately three inches from the loop distal tip.The electrodes were intact with no apparent issues.All electrodes existed on the loop section and no cosmetic issues or anomalies were identified.The shaft was intact with no apparent issues.No kink or any other damage was observed along with the shaft of the mapping catheter.The introducer was intact with no apparent issues.No damage or any other issue were observed along with the introducer.The lemo connector was intact with no apparent issues.No damage or any other issue was observed along with the lemo connector.The functional test was performed using a multimeter.The mapping catheter was connected to the test cable.The continuity and impedance measurement between electrodes and the other side of the cable showed an open circuit between electrode 8 and pin 8.The insertion compatibility inspection was performed with a test balloon catheter and the mapping catheter.The balloon catheter was unable to be inserted into the mapping catheter without resistance due to the mapping catheter's condition.Dissection of the suspected electrode related to the noise, revealed that the electrode wire was broken from the welding at electrode eight.The product issues reported is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.In conclusion, the mapping catheter failed the returned product inspection due to a ribbed material on the pebax tubing, a detached electrode wire at the weld and a pinch at the tip/loop of the pebax tubing.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACHIEVE ADVANCE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18769388
• MDR Text Key: 336182801
• Report Number: 2182208-2024-00721
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K162892
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 8468089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2023
• 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
• Treatment: SEE H11.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male