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

Lot Number 0030503799

Device Problem Material Integrity Problem (2978)

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

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During insertion of an ablation procedure a polarsheath was selected for use.Air embolization was caused by the sheath.There was a temporary st increase approximately 10 minutes after insertion of the balloon catheter into the sheath.The balloon was inflated and deflated at the left superior pulmonary vein (lspv).The st elevation was resolved spontaneously during the procedure.The procedure was completed.The physician commented that air may have been introduced into the sheath when the balloon was inserted.

• 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: 16428163
• MDR Text Key: 310068881
• Report Number: 2124215-2023-07710
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 09/19/2023
• Device Lot Number: 0030503799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other