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

Model Number M004CRBS3050

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that a polarsheath was used in a atrial fibrillation cryoablation procedure.After inserting the catheter into the patient the physician tried to asperate through the side port, but the air was pulled out.The sheath was exchanged and the procedure was completed with no patient injury.

Event Description

It was reported that a polarsheath was used in a atrial fibrillation cryoablation procedure.After inserting the catheter into the patient the physician tried to aspirate through the side port, but the air was pulled out.The sheath was exchanged and the procedure was completed with no patient injury.

Manufacturer Narrative

Visual inspection of the device showed blood within sheath and flush line.A kink was also noted in the flush line.There was no sign of an uncontrolled tear on the surface of the outer slit there and no leaks were 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 in hemostasis testing.There is no evidence this device was used in a manner inconsistent with the labeled indications.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

• 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: 13068564
• MDR Text Key: 285342478
• Report Number: 2134265-2021-16154
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0027506192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1