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

Model Number 2ACH20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, perforation and bleeding from the intubation tube were observed.The patient had lingula removed.The patient was in the intensive care unit (icu) under general anesthesia. the case was completed with cryo. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Event Description

It was later reported that the mapping catheter was suspected to have perforated the left superior pulmonary vein (lspv).The patient remained hospitalized, intubated, and stable two weeks following the procedure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: afapro28 product type: balloon catheter; product id: 4fc12 product type: sheath.Product event summary: the data files and the 2ach20 mapping catheter with lot number 8232178 were returned and analyzed.The patient data files showed at least 21 applications were performed with the 2af284 balloon catheter with lot number 8950 on the reported event date without any system notice.The pressure and flow readings were within range; however, the temperature was reaching around -60°c on the following applications 5, 9, 10, 16, 19 and 20.The failure file and the powerup test file were not available for analysis.Visual inspection of the mapping catheter was performed and the loop was ribbed near electrodes four, five, and six.Electrodes four, five, and six were displaced from their original locations.During functional testing, the continuity and impedance measurement between electrodes and the other side of the cable showed that electrocardiogram (ecg) electrodes four, five, six, seven, and eight to pins four, five, six, seven, and eight were an open circuit.The rest of the channels are normal.Dissection of the suspected electrode related to the noise revealed the electrode wires were broken from the welding at electrodes four and five.It also revealed that the electrode wires were detached from the welding at electrodes six, seven, and eight.In conclusion, the reported clinical issue (perforation and bleeding) occurred during a case.The mapping catheter failed the returned product inspection due to a displaced electrode on the loop of the pebax tubing, a broken electrode wire at the weld, ribbed material on the pebax tubing, and a detached electrode wire at the weld.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: 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: 17920051
• MDR Text Key: 325492161
• Report Number: 2182208-2023-02980
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169590984
• UDI-Public: 00643169590984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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: 8232178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• 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 H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female