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 Cardiac Arrest (1762); Death (1802); Great Vessel Perforation (2152); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/22/2019

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a pericardial effusion was observed.The balloon catheter was positioned twice, but occlusion was not obtained.Cardiac tamponade then occurred.The case was aborted, and the patient was under general anesthesia.An emergent surgery was then performed as the pericardial drainage was not enough to restore the patient's cardiac function.Surgery then revealed a "wound" in the left superior pulmonary vein (lspv), which is the size of the "balloon nose." the patient experienced cardiac arrest, and subsequently died.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Incoming information confirmed that the left superior pulmonary vein (lspv) was perforated.Additionally, the cause of death was perforation.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8272347
• MDR Text Key: 133910031
• Report Number: 9612164-2019-00290
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/21/2019

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: 10/29/2020
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 216466529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/21/2019
• Date Device Manufactured: 10/29/2018
• 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: 4FC12 SHEATH
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 68 YR