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

Model Number 990063-020

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Product event summary: visual inspection of mapping catheter, 990063-020 / 214864046, showed the shaft was kinked and broken at the proximal end attachment with the ecg connector; no ecg signal wires were broken inside the shaft.The product analysis findings do not indicate a manufacturing related defect.In conclusion, the reported broken catheter issue has been confirmed through testing.The mapping catheter failed the returned product inspection due to kinked and broken shaft at ecg connector attachment.If information is provided in the future, a supplemental report will be issued.

Event Description

The mapping catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 8202923
• MDR Text Key: 131617640
• Report Number: 9612164-2018-03783
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 02000012695627
• UDI-Public: 2000012695627
• 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: Other
• Type of Report: Initial
• Report Date: 12/28/2018

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: 02/19/2020
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 214864046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• 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