MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE

Lot Number 0028111883

Device Problem Leak/Splash (1354)

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

Event Date 06/12/2022

Event Type  malfunction  

Event Description

It was reported that during preparation for a cryo ablation procedure using a polarsheath they observed air bubbles entering the sheath through the sheath's valve.When they connected the syringe to the side port of the sheath and aspirated they saw air entering the sheath.They exchanged the sheath and were able to complete the procedure with no patient complications.The sheath is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the sheath was visually inspected and no abnormalities were found.Next the sheath was tested by replicating aspiration.The sheath failed the testing as air was visible in the flushing line every time the syringe was used to create a vacuum.The sheath was disassembled and they confirmed the leak was coming from the hemostatic valve.

Event Description

It was reported that during preparation for a cryo ablation procedure using a polarsheath they observed air bubbles entering the sheath through the sheath's valve.When they connected the syringe to the side port of the sheath and aspirated they saw air entering the sheath.They exchanged the sheath and were able to complete the procedure with no patient complications.The sheath has been returned for analysis.

• Brand Name: POLARSHEATH
• Type of Device: VASCULAR GUIDE CATHETER, SINGLE-USE
• 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: 14987773
• MDR Text Key: 304018002
• Report Number: 2134265-2022-07834
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

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: 08/10/2022
• Device Lot Number: 0028111883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1