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 Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot number 225408518 was returned and analyzed.Visual inspection of the loop segment area showed the loop was detached near the electrodes.It also showed that the loop was kinked and ribbed near the electrodes.The user may have experienced insertion difficulties due to these issues when introducing the mapping catheter into the balloon catheter.Visual inspection of the loop segment also showed the loop was torn and damaged near the electrodes.Visual inspection of the pebax segment area showed the pebax tubing was kinked and ribbed.Visual inspection of the electrodes showed electrode 5 was displaced from its original location, bent, and crushed.The electrodes 1,2,3 were found detached from the pebax tubing and were not returned with the device.Visual inspection of the shaft segment area showed the shaft was broken approximately 6.3 inches from the lemo connector.No ecg signal wires were broken.Visual inspection of the introducer showed the introducer was broken at the proximal end.The lemo connector was not received.The insertion test could not be performed due to the damage of the mapping catheter.In conclusion, the reported entrapment was confirmed.The mapping catheter failed the returned product inspection due to the detached loop, broken introducer, shaft kink, broken shaft, and displaced electrodes.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, the mapping catheter fell into the left ventricle and became entrapped occurred in the chordae tendineae.The mapping catheter was removed from the patient, however parts of the mapping catheter ring remained in the patient.The procedure was aborted and the patient was transported to another facility to remove the mapping catheter parts through a small incision between the ribs.Additionally, a mitral valve replacement and a maze surgery were performed.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: fluoroscopic videos were returned and analyzed.The first video showed the pebax loop was loose during the process retraction and at 20 seconds it shows possible sudden detachment of the tip.The second and third video showed the pebax loop was moving and the tip seems to be loose and kinked.The third video showed the sheath and mapping catheter tip with three electrodes visible.The fourth and fifth video showed the tip of the mapping catheter and sheath.The sixth video showed the mapping catheter pebax visible with the eight electrodes.The seventh video showed the mapping catheter could not be identified.In conclusion, the reported entrapment could not be confirmed through the video analysis.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: 16542720
• MDR Text Key: 311290646
• Report Number: 9617601-2023-00042
• 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: 04/18/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 225408518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization