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

Patient Problems Hematoma (1884); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Perforation (2001); Cough (4457)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: non-medtronic unknown, product type: esophageal temperature catheter 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 patient experienced coughing while the left superior pulmonary vein (lspv) was ablated. bleeding from inside the mouth or near the throat was later discovered while suctioning.It was surmised that another manufacturer's esophageal temperature catheter may have contributed to the bleeding.The case was completed with cryo.The bleeding was determined to be healed, "after removal of the respiratory organs after the surgery," however, blood sputum appeared and a hematoma near the left lung was observed on a computerized tomography (ct) scan.It was surmised there was a perforation from the mapping catheter.The patient was subjected to extended hospitalization.The bleeding stopped and the hematoma improved so the patient was discharged from the hospital five days post-procedure. no further patient complications have been reported as a result of this event.

Event Description

It was later reported that the balloon catheter and sheath were not advanced as deeply as the mapping catheter, and the mapping catheter was inserted and removed several times to advance the depth.It was also reported that "removal of respiratory organs" meant removal of the breathing equipment.

Manufacturer Narrative

Continuation of d10: product id: 4fc12, product type: sheath; product id: afapro28, product type: balloon catheter.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: 19130888
• MDR Text Key: 340446503
• Report Number: 9617601-2024-00063
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 228122731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2024
• 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): Hospitalization; Life Threatening