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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2020

Event Type  malfunction  

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

During a pulmonary vein isolation cryoablation procedure, a polarsheath was selected for use.It was reported that after the sheath was inserted into the patient and irrigation was connected, blood leakage was observed from the hemostatic valve.The sheath was exchanged and the procedure was completed successfully.No patient complications were reported and the patient's current condition is fine.

Event Description

During a pulmonary vein isolation cryoablation procedure , a polarsheath was selected for use.It was reported that after the sheath was inserted into the patient and irrigation was connected, blood leakage was observed from the hemostatic valve.The sheath was exchanged and the procedure was completed successfully.No patient complications were reported and the patient's current condition is fine.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Initial visual and microscope inspections of the valve showed revealed a small tear/puncture through the outer valve seal.The device passed pressure decay testing at 6 psi and hemostasis testing at 5.5 psi pressurization with saline.The device did not pass aspiration with 10 cc and 60 cc syringe at various flowrates.Air pressure testing was performed to identify the location of any potential leaks.The device was gently pressurized at the flushing line luer fitting while plugging the distal tip of the catheter; the measurements were within the acceptable range and no air bubbles were observed laboratory analysis confirmed the reported clinical observations.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: 10695559
• MDR Text Key: 213659352
• Report Number: 2134265-2020-14324
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025818181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 11/23/2020
• Patient Sequence Number: 1