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 Appropriate Term/Code Not Available (3191)

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

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot 225452068 was returned and analyzed.Visual inspection was performed, and bond damage was observed at the shaft to the tube fitting.Additionally, a ribbed material was observed on the tubing.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 segment area showed the tubing was ribbed at approximately 2.5 inches from the loop distal tip.Visual inspection of the segment area showed the tubing at the shaft fitting joint was damaged/kinked, and the outer diameter of tubing/shaft joint should be at <(><<)>(> <(><<)><(><<)>)>0.043 inches.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 the introducer/loop straightener was removed from the returned achieve mapping catheter.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.In conclusion, the mapping catheter failed the returned product inspection due to bond damage on the shaft fitting joint and ribbed tubing.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.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, the mapping catheter could not be inserted into the lumen of the balloon catheter.The mapping catheter was replaced without resolution.Subsequently, the balloon catheter was replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the returned mapping catheter was attempted to be inserted into the returned balloon catheter and was unsuccessful.Dissection and further inspection under microscope and measurement identified the inner diameter of the end of the funnel of the luer was measured out of specification.The id of the guidewire luer measured 0.041 inches (not within the specification >0.044 inches).The smaller inner diameter of the luer was identified as the cause for insertion difficulties.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: 16996393
• MDR Text Key: 316105307
• Report Number: 3002648230-2023-00261
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 225452068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• 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