MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE

Lot Number 0030027921

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Heart Block (4444)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a cryo-ablation pulmonary vein isolation procedure to treat atrial fibrillation (a fib) using a polarsheath air bubbles were noticed and the patient experienced st segment elevation and heart block.During use of the sheath the physician saw air bubbles.St segment elevation was noted, and heart block was identified.The condition was resolved by pacing the right ventricle.The procedure was completed using the original device with no further patient complications, following the procedure the patient was reported as having fully recovered.They were not able to determine the exact source of the air.The sheath will not be returned for analysis as it was disposed of by the facility after the procedure.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16431148
• MDR Text Key: 310102271
• Report Number: 2124215-2023-08533
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Lot Number: 0030027921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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): Required Intervention