MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE 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 Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Coma (2417); Respiratory Failure (2484); Pericardial Effusion (3271)

Event Date 04/08/2020

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 cryoablation procedure, the patient had a drop in blood pressure.An echocardiogram was performed and a cardiac effusion was observed.A pericardiocentesis was performed.The case was completed with cryo.It was further indicated that three days following the procedure, the patient died.

Event Description

Additional information indicated when placing the system on the septal pulmonary veins, it was dislocated in the right atrium.It was re-positioned in the left atrium.A cardiac tamponade was confirmed following the maneuver.The patient was transferred to intensive care.Three days later, with hemodynamics restored following the percutaneous drainage, the patient presented with respiratory arrest that was treated with mechanical ventilation.The patient remained in an irreversible coma and died 22 days after the procedure.It was noted the sequence of events was attributed to the patient's fragility and comorbidities (chronic obstructive pulmonary disease, irc).

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: ACHIEVE ADVANCE 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
• MDR Report Key: 10196549
• MDR Text Key: 196469283
• Report Number: 2182208-2020-01165
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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 Expiration Date: 03/20/2021
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 11133427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFAPRO28 BALLOON CATHETER, 4FC12 SHEATH
• Patient Outcome(s): Death