MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004CRBSUSC3050

Device Problem Leak/Splash (1354)

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

Event Date 03/23/2021

Event Type  Injury  

Event Description

Clinical study frozen af py004.It was reported that during a cryoablation procedure to treat atrial fibrillation, the polarsheath was inserted at approximately 12:40 without incident.Following seven cryoablation treatments, the balloon catheter was removed and a non-boston scientific catheter was inserted to check for entrance and exit block.The non-boston scientific catheter was removed and the polarx balloon was reinserted for the eighth cryo treatment.The balloon was removed and the non-boston scientific catheter was reinserted to confirm entrance and exit block in the right superior pulmonary vein (rspv).The balloon was reinserted, and shortly after st changes were noted.First, the 12 lead electrocardiogram (ecg) showed st segment elevation at 13:58, next the ecg showed resolving st segment elevation at 14:02, and another showed further resolution was at 14:04.Aspiration of any residual air from the sidearm of the sheath followed by flushing the sheath.The balloon was removed during the left heart catheterization (lhc) and once the st segment elevation had resolved, and the right coronary artery (rca) and left coronary artery (lca) were noted to be clear, the balloon was reinserted for the final cryo application in the rspv.The physician continued to aspirate and flush with any additional catheter exchanges.The left ventricle function was observed with intracardiac echocardiogram (ice).The physician noted that there was air being pulled into the syringe during aspiration attempts, which were eventually able to be cleared.The non-boston scientific catheter was inserted one last time to confirm entrance and exit block in the rspv and the procedure was completed.There were no apparent lasting sequalae and the event resolved.The patient was to be discharged on schedule and was not admitted to the hospital beyond the standard of care.They did not recall if the dilator wiped with saline prior to introduction into the valve.The sheath was fully flushed before the dilator was inserted.The non-boston scientific mapping catheter and polarx cryo balloon catheter were placed across the valve.The main issue with air ingress was noted during flushing of the sheath between exchanges of the non-boston scientific catheter and the polarx balloon catheter.It was air ingress through the valve that occurred and not leaking.The suspected cause was reported as a "possible air embolus from the polarsheath." the sheath was left in place for the entire procedure.The device has been returned to boston scientific and is pending analysis.

Manufacturer Narrative

The device was returned to boston scientific for analysis.As received, the valve seal post cleaning showed no visible puncture/tear on outer slit, but a possible c-shaped tear on inner slit.Visual inspection showed blood on the handle and shaft.The 3-way stopcock was within field.Functional testing was performed.The received polarsheath passed all standard and extensive engineering pressure decay, aspiration, and hemostasis testing procedures.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Clinical study frozen (b)(6).It was reported that during a cryoablation procedure to treat atrial fibrillation, the polarsheath was inserted at approximately 12:40 without incident.Following seven cryoablation treatments, the balloon catheter was removed and a non-boston scientific catheter was inserted to check for entrance and exit block.The non-boston scientific catheter was removed and the polarx balloon was reinserted for the eighth cryo treatment.The balloon was removed and the non-boston scientific catheter was reinserted to confirm entrance and exit block in the right superior pulmonary vein (rspv).The balloon was reinserted, and shortly after st changes were noted.First, the 12 lead electrocardiogram (ecg) showed st segment elevation at 13:58, next the ecg showed resolving st segment elevation at 14:02, and another showed further resolution was at 14:04.Aspiration of any residual air from the sidearm of the sheath followed by flushing the sheath.The balloon was removed during the left heart catheterization (lhc) and once the st segment elevation had resolved, and the right coronary artery (rca) and left coronary artery (lca) were noted to be clear, the balloon was reinserted for the final cryo application in the rspv.The physician continued to aspirate and flush with any additional catheter exchanges.The left ventricle function was observed with intracardiac echocardiogram (ice).The physician noted that there was air being pulled into the syringe during aspiration attempts, which were eventually able to be cleared.The non-boston scientific catheter was inserted one last time to confirm entrance and exit block in the rspv and the procedure was completed.There were no apparent lasting sequalae and the event resolved.The patient was to be discharged on schedule and was not admitted to the hospital beyond the standard of care.They did not recall if the dilator wiped with saline prior to introduction into the valve.The sheath was fully flushed before the dilator was inserted.The non-boston scientific mapping catheter and polarx cryo balloon catheter were placed across the valve.The main issue with air ingress was noted during flushing of the sheath between exchanges of the non-boston scientific catheter and the polarx balloon catheter.It was air ingress through the valve that occurred and not leaking.The suspected cause was reported as a "possible air embolus from the polarsheath." the sheath was left in place for the entire procedure.The device has been returned to boston scientific and is pending analysis.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 11619346
• MDR Text Key: 243947684
• Report Number: 2134265-2021-04407
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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: 08/25/2021
• Device Model Number: M004CRBSUSC3050
• Device Lot Number: 0026185091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/02/2021
• Supplement Dates FDA Received: 05/06/2021
• Patient Sequence Number: 1
• Treatment: BIOSENSE WEBSTER PENTARAY CATHETER.; BIOSENSE WEBSTER PENTARAY CATHETER.; BIOSENSE WEBSTER PENTARAY CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR