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
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cryo ablation procedure, the mapping catheter would not pass through lumen of the balloon catheter. introducer was working properly. the copilot was adjusted without resolve.The mapping catheter was replaced without resolve.The balloon catheter was then replaced to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 990063-020 mapping catheter with lot number 226872941 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 segment area showed the pebax tubing at the shaft fitting joint was damaged/kinked.The user may have experience insertion difficulties due to this issue when introducing the mapping catheter into the balloon catheter.Visual inspection of the electrodes showed the electrodes 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 53 inches from the lemo connector.Visual inspection of the introducer showed the introducer was broken at the proximal end and the introducer was removed.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 the electrodes and the ot her side of the cable showed the electrode's continuity and impedance to the cable are normal.In conclusion, the mapping catheter failed the returned product inspection due to the kink observed on the catheter shaft, a broken/detached introducer was observed at the tubing proximal end, the introducer was removed from the mapping catheter, and bond damage was observed at the shaft to the pebax tube fitting.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.
Additional Manufacturer Narrative
**udi related data quality updates only**   corrected: d4 (provide complete udi).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
• Common Device Name: 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: 18028601
• Report Number: 9617601-2023-00220
• Device Sequence Number: 20352137
• Product Code: DRF
• UDI-Device Identifier: 00643169467385
• UDI-Public: (01)00643169467385(17)250727(1
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2025
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 226872941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female