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 Signal Artifact/Noise (1036); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/25/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that during a cryo ablation procedure, the mapping catheter showed severe interference.The mapping catheter cables was replaced three times without resolution, the plug-in board of the multiconductor was then replaced without resolution.The signal potential of the other electrophysiological diagnostic electrodes were as expected.The case was aborted, the patient was not under general anesthesia.After the procedure the patient developed a delayed cardiac tamponade.It is unknown if hospitalization was extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The mapping catheter was discarded and was not returned for analysis.Five files containing images and a video file were received.The first image file showed severe interference as well as on the second picture.The third image file showed the lemo connector of the mapping catheter connected to the mapping catheter cables.On the fourth picture showed the mapping catheter cables connected to the electrocardiogram (ecg) box.There was also a short video file showing the mapping catheter signal interference on the monitoring screen.In conclusion, the reported signal interference issues were confirmed.The reported pericardial effusion occurred during the procedure but could not be confirmed through data analysis.There is no indication of a relation of the adverse event to the performance and malfunction of the product.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.

Event Description

It was later reported that the patient had a pericardial effusion and not a cardiac tamponade.The pericardial effusion effusion gradually absorbed itself twenty four days after the onset of symptoms.The patient hospitalization was extended for three days and then discharged.

Manufacturer Narrative

Correction: it was previously stated that mapping catheter was discarded but in fact the customer originally refused return.The product was later received for analysis.Product event summary: the 990063-020 mapping catheter with lot number 228122733 was returned and analyzed.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 mapping catheter.Visual inspection of the pebax tubing area showed the pebax tubing was intact with no apparent issues.No damage was observed along with the pebax 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 shaft segment area showed the shaft was intact with no apparent issues.No kink or any other damage was observed along with the shaft of the mapping catheter.Visual inspection of the introducer showed that the introducer was broken at the proximal end.Visual inspection of the lemo connector showed 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 the electrocardiogram (ecg) electrode 5 to pin 5 was an open circuit.Due to this, the user may experience signal noise/lack of signal issue.The rest of the channels were normal.Dissection of the suspected electrode related to the noise revealed the electrode wire(s) was broken from the welding at electrode(s).In conclusion, reported pericardial effusion could not be confirmed through product analysis, the signal issues were observed in the data files.The mapping catheter failed the return product inspection due to a broken electrode wire and a broken/detached introducer at the tubing at the proximal end.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 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: 19212298
• MDR Text Key: 341372711
• Report Number: 9617601-2024-00074
• 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: 05/13/2024

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: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 228122733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2024
• 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 Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG