MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 0028853609

Device Problem Leak/Splash (1354)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.

Event Description

It was reported that during a cryoablation procedure, after inserting the polarsheath in the left atrium, blood came back from the valve.As a result, this sheath was replaced and the procedure was completed without patient complications.This sheath is expected to be returned for laboratory analysis.

Manufacturer Narrative

The polarsheath has been received for laboratory analysis.Visual inspection did not reveal any abnormalities.The sheath was returned with the dilator inserted in the sheath.The sheath failed all standard manufacturing testing with a leak in the pressure decay test, visible bubbles in the flush line during aspiration and dropping pressure while pressurized at 5.5 psi in hemostasis testing.Laboratory analysis was able to confirm the reported clinical observations.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

It was reported that during a cryoablation procedure, after inserting the polarsheath in the left atrium, blood came back from the valve without inserting the polarx catheter.This sheath was replaced and the procedure was completed without patient complications.This sheath has been returned for laboratory analysis.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 14977475
• MDR Text Key: 303581823
• Report Number: 2134265-2022-07788
• Device Sequence Number: 1
• Product Code: DRF
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2022
• Device Lot Number: 0028853609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1