MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER - 20 MM; 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); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 06/16/2020

Event Type  Death  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that seventeen applications were performed with the balloon catheter, 2af284 with lot 00437 without any issue on the date of the event.Clinical issues were encountered during the procedure.There is no relation of adverse event to the performance and malfunction of the product.The physical product was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a successful cryo ablation procedure, a complication was noted by the anesthesia team.The patient's blood pressure dropped, cardiopulmonary resuscitation (cpr) was attempted, and was unsuccessful.The patient died.Incoming information indicated that the cause of death was cardiac tamponade.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10263725
• MDR Text Key: 198507906
• Report Number: 9612164-2020-02556
• Device Sequence Number: 1
• Product Code: DRF
• 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: 07/13/2020

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 Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 29 YR