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

Model Number 990063-020

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

Patient Problems Hematoma (1884); Perforation (2001); Pericardial Effusion (3271)

Event Date 11/30/2017

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, a stain was still observed due to contrast media remained in the right inferior pulmonary vein (ripv).It was noted that during the cavo tricuspid isthums ablation, fluoroscopy was checked to confirm balloon occlusion in the ripv, there was oozing in the pericardial sac.Additionally, resistance was noted when using the mapping catheter.The case was completed with cryo.Post operatively to the procedure, protamine was used to perform heparin reversal.The patient was placed under monitoring in the coronary care unit (ccu).A perforation in the ripv was noted, along with a "probable" mediastinal hematoma.A pericardial effusion was also observed.Further information received indicates that there was no therapeutic intervention reported and no treatment was performed for the hematoma.There were no additional patient symptoms reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files were returned and analyzed.Data files showed that at least eight applications were performed with the balloon catheter without any issues or system notices on the date of event.Product analysis findings of the data files did not indicate a manufacturing related defect.In conclusion, clinical issues (pericardial effusion and cardiac tamponade) were encountered during the procedure.Also, there were no indications of product a malfunction.The physical device was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

• 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: 7135896
• MDR Text Key: 95448554
• Report Number: 9612164-2017-02030
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 213802550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR