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 Death (1802); Low Blood Pressure/ Hypotension (1914); Vasoconstriction (2126); Cardiac Perforation (2513)

Event Date 01/02/2019

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, following transseptal puncture, a competitor product was replaced with the manufacturer sheath.Once the sheath was in the left atrium, a competitor product was replaced with the manufacturer mapping catheter, and a 3d electroanatomical map was created using a competitor mapping system.While mapping, it was observed that the patient's blood pressure was low, and as the physician indicated that there was a small baseline effusion, an intracardiac catheter was used to check for any changes in the effusion.While checking, the picture quality of the ice has diminished significantly, however, the physician could not see a change.As the patient's blood pressure remains low, medications were given, and the case continued.After the mapping was complete, the manufacturer mapping catheter was removed, and was inserted into the manufacturer balloon catheter.The balloon catheter was then inserted into the left atrium, via the sheath.It was also reported that there was a possible vasospasm when the left superior pulmonary vein (lspv) was tested with adenosine.The procedure continued, and once the balloon catheter entered the left atrium, and then subsequently moved to the left inferior pulmonary vein (lipv), the pressure transducer that is used to assess pv occlusion was not functioning properly, and the ice picture quality had gotten worse.The physician then made the decision to rely solely on contrast and fluoroscopy for the remainder of the case.The procedure continued, and upon moving the balloon catheter to the right sided veins, the heart border was not moving.At this time, the ice had stopped working completely, and a stat echocardiogram was ordered, and chest compressions were initiated.A decision was then made by the physician and surgical team to open the patient's chest, and a large tear was found.The tear extended from the left superior pulmonary vein (lspv) to the posterior portion of the carina and into the left inferior pulmonary vein (lipv).Despite the surgeon's best efforts, the tear could not be repaired.The patient subsequently died.Additional information reported that the transeptal needle was likely the cause of the injury but without continuous arterial pressure monitoring during the case, there was no way to know without any doubt exactly when the injury occurred.Also, the patient had a laryngeal mask airway (lma) instead of being intubated because of tough patient anatomy.The injury was repaired but the time it took to intubate the patient was the biggest contributor to the injury progressing to death.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8272572
• MDR Text Key: 133931360
• Report Number: 2182208-2019-00150
• 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: 01/23/2019

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 Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/23/2019
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 74