MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least fourteen applications were performed with catheter 2af284 / 33900-68 on the date of the event with no system notice or any issues.Visual inspection of mapping catheter, 990063-020 / 214709065, results showed the catheter was kinked on the loop (misshape) and all 8 electrodes were missing (detached) from the loop and not included in the biohazard package.The mapping catheter failed the test due to kink on the loop (misshape) and electrodes missing from the loop.The product analysis findings do not indicate a manufacturing related defect.In conclusion, the reported issues (#50005 ¿fluid detection in catheter¿, electrode detached) have been confirmed through testing but not confirmed through the data analysis.The achieve mapping catheter failed the returned product inspection due to loop misshape and all electrodes missing (detached) from the loop.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, upon preparing the balloon catheter for reinsertion, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.Additionally, fluid was seen on the catheter.It was also reported that upon removing the mapping catheter from the balloon catheter, the electrodes had been stripped off.The case was completed with radiofrequency ablation.No patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7540963
• MDR Text Key: 109156010
• Report Number: 9612164-2018-01220
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169467385
• UDI-Public: 00643169467385
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2018

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 Expiration Date: 01/22/2020
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 214709065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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