MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969); Paralysis (1997); Paresis (1998); ST Segment Elevation (2059)

Event Date 07/09/2018

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, 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.

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 sheath 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

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.It was also indicated that the physician did not regard the manufacturer sheath to be defective.

Manufacturer Narrative

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

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: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 7735006
• MDR Text Key: 115552999
• Report Number: 3002648230-2018-00512
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 21200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2AF284 CATHETER; 990063-020 MAPPING CATHETER; 2AF284 CATHETER
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 52 YR