MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Model Number M004CRBS3050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non specific EKG/ECG Changes (1817); Ventricular Fibrillation (2130)

Event Date 06/24/2021

Event Type  Death  

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

A persistent atrial fibrillation procedure on (b)(6) year-old female patient was scheduled.A dynamc xt coronary sinus catheter was used to gain femoral access.A non-boston scientific sheath and a non-boston scientific transeptal needle were used to complete the transeptal puncture with fluoroscopic guidance.The sheath was advanced into the left atrium then the polarsheath was prepped for use.The polarsheat was flushed with saline solution then a 3-way stopcock was attached to the sheath handle.Both were flushed again including the sheath lumen and ports of the stopcock.Then, the dilator was flushed prior to insertion into the sheath.The sheath and dilator set-up was flushed again.With fluoroscopic guidance, the physician introduced the polarsheath into the right femoral vein over the guidewire.It was advanced up to the right atrium and crossing transeptal puncture.With the 3-way stopcock holder positioned in the direction of the sheath (closed) the physician slow removed the dilator until it was outside of the sheath.With a syringe connected to the side port of the stopcock, the holder was rotated so the stopcock was opened.Blood flow was confirmed to be coming out from the side port of the sheath and into the syringe.No air ingress was observed.A lot flow saline solution pressure bag was connected to the sideport of the stopcock to irrigate the sheath.After few minutes, an st elevation was observed before the introduction of the polarx balloon catheter and polarmap catheter.The polarsheath was removed from the patient and an echocardiograph was performed.A ventricular fibrillation episode occurred a few minutes after, followed by several electrical cardioversions with temporary, but not stable, restoration of sinus rhythm until the patient expired.The polarx and polarmap catheters were never used inside the patient.The official cause of death is unknown.No imaging were collected during the case currently available.Since the event occurred during the first phase of the procedure, only local anesthesia was used for femoral accesses).During this phase, no snoring or deep breathing was observed.No difficulties was observed during transeptal puncture.The patient did not have underlying coronary artery disease, heart failure, and/or cardiomyopathy.The physician id not allege any problems with the products or the maneuvers performed.

Event Description

A persistent atrial fibrillation procedure on 72 year-old female patient was scheduled.A dynamc xt coronary sinus catheter was used to gain femoral access.A non-boston scientific sheath and a non-boston scientific transeptal needle were used to complete the transeptal puncture with fluoroscopic guidance.The sheath was advanced into the left atrium then the polarsheath was prepped for use.The polarsheath was flushed with saline solution then a 3-way stopcock was attached to the sheath handle.Both were flushed again including the sheath lumen and ports of the stopcock.Then, the dilator was flushed prior to insertion into the sheath.The sheath and dilator set-up was flushed again.With fluoroscopic guidance, the physician introduced the polarsheath into the right femoral vein over the guidewire.It was advanced up to the right atrium and crossing transeptal puncture.With the 3-way stopcock holder positioned in the direction of the sheath (closed) the physician slow removed the dilator until it was outside of the sheath.With a syringe connected to the side port of the stopcock, the holder was rotated so the stopcock was opened.Blood flow was confirmed to be coming out from the side port of the sheath and into the syringe.No air ingress was observed.A lot flow saline solution pressure bag was connected to the sideport of the stopcock to irrigate the sheath.After few minutes, an st elevation was observed before the introduction of the polarx balloon catheter and polarmap catheter.The polarsheath was removed from the patient and an echocardiograph was performed.A ventricular fibrillation episode occurred a few minutes after, followed by several electrical cardioversions with temporary, but not stable, restoration of sinus rhythm until the patient expired.The polarx and polarmap catheters were never used inside the patient.The official cause of death is unknown.No imaging were collected during the case currently available.Since the event occurred during the first phase of the procedure, only local anesthesia was used for femoral accesses).During this phase, no snoring or deep breathing was observed.No difficulties was observed during transeptal puncture.The patient did not have underlying coronary artery disease, heart failure, and/or cardiomyopathy.The physician id not allege any problems with the products or the maneuvers performed.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection did not note any abnormalities.Microscopic examination revealed a tar on the outer slit of the valve seal.The sheath passed all functional testing including the aspiration test, the hemostasis valve test, and the air pressure test for leaks.No leakage, dripping or pressure drop was observed.No signs of bubbles in the flushing line were seen during testing.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 (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 12108076
• MDR Text Key: 259642492
• Report Number: 2134265-2021-08480
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026027032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR