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

Model Number 2ACH20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least 7 applications were performed with balloon catheter 2af284 with lot number 85292, without any issue on the date of the event.Clinical issues were encountered during the procedure.There is no indication of a relation of the adverse events to the performance of the physical product.The mapping catheter was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, vital signs were not stable and an epicardial effusion was observed by an echocardiogram.A pericardial puncture was performed to drain the effusion.It was further reported that bleeding could not be stopped, and the patient was transferred to the cardiac department of another facility.The case was aborted and it was noted that the patient was not under general anesthesia.The physician noted that a perforation occurred before the balloon catheter was inserted.No further 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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8202008
• MDR Text Key: 131597495
• Report Number: 2182208-2018-02339
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 11023564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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
• Treatment: 2AF284 BALLOON CATHETER, 4FC12 SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention