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 Problem Pericardial Effusion (3271)

Event Date 12/02/2021

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.

Event Description

It was reported that a polarx, polarsheath and polarmap were used in a paroxysmal af (de novo) cryoablation procedure.The physician guided the polarsheath over a guidewire without resistance, trans-septal into the left atrium.While inserting the polarx balloon into the polarsheath and reaching the ostium of the lspv.After inflating the polarx balloon, no visible signs of cardiac decompensation were noted.Only after administration of contrast agent for occlusion assessment did the blood pressure drop significantly and under fluoroscopy the contrast medium showed an unnatural flow behavior.The physician decided to stop the procedure immediately, and asked for a quick heart ultrasound investigation.A fulminant pericardial effusion was immediately recognizable, which prompted the physician for an emergency case and to puncture the effusion externally.After 1 1/2 liters of blood had been withdrawn, the patient's condition stabilized even under the administration of volume and drugs.The polarx, polarsheath and polarmap devices were removed without performing ablation.The devices are expected to be returned to boston scientific for analysis.

Manufacturer Narrative

Visual inspection of the device showed kinks in main shaft.Blood was observed in the flush-line.Salt particles on steering knob and a clenched distal end of main shaft were also noted.There was a small uncontrolled tear on the surface of the outer slit yet leaks were not observed.The sheath passed all standard manufacturing testing without any leak values in the pressure decay test; no visible bubbles in the flush line during aspiration through various speeds; and no dripping liquid leaks from the proximal end while pressurized at 5.5 psi in hemostasis testing.Steering also held deflection without holding steering knob.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a polarx, polarsheath and polarmap were used in a paroxysmal af (de novo) cryoablation procedure.The physician guided the polarsheath over a guidewire without resistance, trans-septal into the left atrium.While inserting the polarx balloon into the polarsheath and reaching the ostium of the lspv.After inflating the polarx balloon, no visible signs of cardiac decompensation were noted.Only after administration of contrast agent for occlusion assessment did the blood pressure drop significantly and under fluoroscopy the contrast medium showed an unnatural flow behavior.The physician decided to stop the procedure immediately, and asked for a quick heart ultrasound investigation.A fulminant pericardial effusion was immediately recognizable, which prompted the physician for an emergency case and to puncture the effusion externally.After 1 1/2 liters of blood had been withdrawn, the patient's condition stabilized even under the administration of volume and drugs.The polarx, polarsheath and polarmap devices were removed without performing ablation.The devices have been returned to boston scientific for analysis.

• 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: 13014165
• MDR Text Key: 282322914
• Report Number: 2134265-2021-15847
• 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
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0027856152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention