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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Human-Device Interface Problem (2949)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); ST Segment Elevation (2059); Vaso-Vagal Response (2661)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device was disposed and 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 the polarsheath hemostatic valve was leaking blood and sucking air; the patient became vagal, due to either cardioplegia or an air embolism, and had to be resuscitated.It was noted that the sheath was too soft making it difficult to create the necessary pressure with the balloon on the veins.The hemostatic valve was leaking blood and eventually sucking air.After the first ablation, the patient became vagal and had to be resuscitated, possibly due to cardioplegia effect of cold blood after ablation, or due to air ingress into the sheath.Additional information was received clarifying the reported events.The medical team prepared the sheath for use per standard procedures.The dilator was wetted prior to insertion into the sheath.The irrigation line was attached, and standard air management was performed.The sheath and dilator were inserted into the groin and across the septum.The dilator was removed, and blood was aspirated through the sheath side port.Aspiration was performed without covering the sheath valve.No air bubbles were observed, indicating the valve was not compromised up to this point in the procedure.A 5f angio catheter was inserted into the sheath and pulmonary vein angiography was performed.The angio catheter removed and the polarx catheter inserted.It was unknown precisely when the sheath began to leak, but the boston scientific representative believed it started sometime between insertion of the 5f angio catheter and the first ablation in the left superior pulmonary vein (lspv).The leak was characterized as blood coming out "drop by drop" not "flowing out." the physician completed the procedure without replacing the sheath.The patient's heart rate was low at the beginning of the procedure and was decreasing prior to treatment.The first cryo application was applied to the lspv.After thawing of the lsvp ablation, the patient had severe vagal response.The physician had not placed an ep catheter in the heart for emergency pacing; resuscitation is his standard of care.Following the procedure, the physician mentioned that the sheath "pulled in air" and the patient had an st elevation.It was reported that during the procedure, the physician had not mentioned air being pulled into the sheath and did not suggest or request sheath replacement.The boston scientific representative observed blood dripping from the sheath but did not observe any indication of air ingress into the sheath valve or irrigation line.The boston scientific representative also did not hear the physician mention st elevation, nor did the representative observe any monitoring or intervention related to resolving an st elevation.The sheath was discarded and is therefore not available for return to boston scientific for evaluation.

• Brand Name: POLARSHEATH
• 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: 10421508
• MDR Text Key: 203473974
• Report Number: 2134265-2020-11294
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: M004CRBS3050
• Device Catalogue Number: M004CRBS3050
• Device Lot Number: 0025634106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention