MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number 990063-020

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/10/2023

Event Type  Injury  

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 reported that during a cryo ablation procedure, after the replacement of the sheath and balloon catheter self test, the patient blood pressure was measured and was found to be hypotensive.The patient was noted to be in pain.Cardiac tamponade and pericardial effusion were confirmed.The pericardial effusion drainage was performed.The procedure was aborted.The patient was not under general anesthesia.The patient hospitalization was extended; the patient was observed for 3 days after drainage of the pericardial effusion and then was discharged.The patient was later referred for a cardiac ultrasound examination. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot 224840572 was returned and analyzed.Visual inspection was performed, and a broken/detached introducer was observed at the tubing proximal end, and a kink/twist was observed on the catheter shaft.Visual inspection of the loop segment area showed the loop was intact with no apparent issues.No damage was observed along with the tip/loop section of the achieve mapping catheter.Visual inspection of the tubing area showed the tubing was intact with no apparent issues.No damage was observed along with the tubing section of the mapping catheter.Visual inspection of the electrode(s) showed the electrode(s)were intact with no apparent issues.All electrodes exist on the loop section and no cosmetic issue or anomalies were identified.Visual inspection of the shaft segment area showed the shaft was kinked approximately 12 inches from the connector.Visual inspection of the introducer showed the introducer was broken at the proximal end.Visual inspection of the connector showed the connector was intact with no apparent issues.No damage or any other issue was observed along with the connector.Functional testing was performed.The mapping catheter was connected to the test cable; the continuity and impedance measurement between the electrodes and the other side of the cable showed the electrode's continuity and impedance to the cable were normal.In conclusion, the reported issue (cardiac tamponade and hypotension) cannot be assessed through product analysis.The mapping catheter failed the returned product inspection due to a broken introducer and a shaft kink.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 MAPPING CATHETER - 20 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16892438
• MDR Text Key: 314805168
• Report Number: 9617601-2023-00101
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102588
• 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: 06/21/2023

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: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 224840572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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
• Treatment: SHEATH 4FC12.
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization