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 Air Embolism (1697); Stroke/CVA (1770); Death (1802); Paresis (1998); ST Segment Elevation (2059)

Event Date 07/09/2018

Event Type  Death  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed and showed at least one injection was performed with balloon catheter 2af284 with lot number 49772 on the date of the event without triggering any system notices.The mapping catheter was not returned for investigation.Clinical adverse events were encountered during the procedure.There is no indication of the reported adverse events being related to the manufacturing or performance of the device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the balloon catheter was inserted in the sheath, and as it was advanced near the sheath tip, st elevation was observed.The ischemia team was called, and a coronary angiography (cag) was performed, which showed an air embolism.It was noted that the patient's right side of the body might be paralyzed after checking the pupil of the eye.The patient was moved to another room to undergo a computed tomography (ct scan) and the procedure was then aborted.It was unknown if the patient was under general anesthesia.It was noted that the patient died one week after the procedure.Incoming information received indicated that due to the air embolism, extensive cerebral infarction occurred.Additionally, the cause of the cardiac arrest was the exacerbation of the cerebral edema.

Manufacturer Narrative

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

Event Description

Incoming information indicated that the official cause of death was due to the patients underlying condition of atrial fibrillation and that the cerebral infarction was consistent with the air embolism of the middle cerebral artery.

• 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
• MDR Report Key: 7837989
• MDR Text Key: 118924314
• Report Number: 9612164-2018-02238
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K102588
• 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: 07/08/2020

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: 02/12/2020
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 214822745
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FC12 SHEATH, 2AF284 BALLOON CATHETER; 4FC12 SHEATH, 2AF284 BALLOON CATHETER
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 52 YR