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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817)

Event Date 09/22/2021

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.To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (b)(4) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.

Event Description

During an pulmonary vein isolation (pvi) cryoablation procedure to treat atrial fibrillation (af) a polarsheath was selected for use.After bringing the polarsheath forward and removing the dilator, approximately 20ml of air was observed.Angiography of all four veins was performed, the patient became bradycardic with st elevation.Air embolism was diagnosed.The artery which was blocked by air as recanalized.The cryoablation procedure was cancelled and the patient was stable and transferred to intensive care unit for observation.The patient has fully recovered.The device is expected to be returned to boston scientific for analysis.This product is part of the (b)(4) advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

The polarsheath was returned to boston scientific for analysis.Visual inspection noted blood on the sheath and inside the three-way stopcock.The sheath passed all standard manufacturing testing including aspiration, hemostatsis valve, and air pressure tests.An uncontrolled tear was observed on the surface of the outer slit, however, no leaks were seen.Consequently the reported field observation was not confirmed through analysis.To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.

Event Description

During an pulmonary vein isolation (pvi) cryoablation procedure to treat atrial fibrillation (af) a polarsheath was selected for use.After bringing the polarsheath forward and removing the dilator, approximately 20ml of air was observed.Angiography of all four veins was performed, the patient became bradycardic with st elevation.Air embolism was diagnosed.The artery which was blocked by air as recanalized.The cryoablation procedure was cancelled and the patient was stable and transferred to intensive care unit for observation.The patient has fully recovered.Additional information received indicated that the physician suspected that the air ingress occurred during manipulation of the multi-purpose catheter within the sheath during angiography procedure.Air was visible in the coronary artery and was resolved by flushing with saline for approximately 15 minutes.After treatment, the patient had no additional symptoms and did not require additional hospitalization.The device has been returned to boston scientific for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Event Description

During an pulmonary vein isolation (pvi) cryoablation procedure to treat atrial fibrillation (af) a polarsheath was selected for use.After bringing the polarsheath forward and removing the dilator, approximately 20ml of air was observed.Angiography of all four veins was performed, the patient became bradycardic with st elevation.Air embolism was diagnosed.The artery which was blocked by air as recanalized.The cryoablation procedure was cancelled and the patient was stable and transferred to intensive care unit for observation.The patient has fully recovered.Additional information received indicated that the physician suspected that the air ingress occurred during manipulation of the multi-purpose catheter within the sheath during angiography procedure.Air was visible in the coronary artery and was resolved by flushing with saline for approximately 15 minutes.After treatment, the patient had no additional symptoms and did not require additional hospitalization.The device has been returned to boston scientific for analysis.This product is part of the (b)(4) advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

Additional information added to b5.To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.

• 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: 12591289
• MDR Text Key: 275383248
• Report Number: 2134265-2021-12574
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0027353327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 10/13/2021; 11/30/2021
• Supplement Dates FDA Received: 11/09/2021; 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention