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 12/02/2021

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

It was reported that during a polarsheath was selected for use on a cryoablation procedure.While advancing the catheter into the sheath, aspiration from the sheath side port was performed to avoid air contamination.In this case, more air bubbles than usual were observed in the aspirated blood.The procedure was completed using the same polarsheath.At the conclusion of the procedure, coronary angiogram (cag) was performed and confirmed that there was no thrombus formation.

Manufacturer Narrative

Type of reportable event h1: corrected from serious injury to malfunction.The device was received at boston scientific for analysis.Visual inspection noted blood on the handle and the in flush-line of the sheath.Functional tests were performed, and there were no signs of bubbles in the flushing line during the test/syringe vacuum.Hemostatic valve testing was performed, and the device passed the test method as currently released without a dilator inserted during the test.No leakage, dripping and/or pressure drop was observed through the hemostatic valve, nor the flush-line side port.The device was gently pressurized with 6 psi at the flushing line lure fitting while plugging the distal tip of the catheter, using an isacc tester.The valve body was then submerged in a beaker of water, and no bubbles appeared.The pressure decay value passed as 0.0087.The device was under a pumping process for 5 minutes, and no issues appeared on the metriq pumping system.The reported event was not confirmed.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a polarsheath was selected for use during a cryoablation procedure.While advancing the catheter into the sheath, aspiration from the sheath side port was performed to avoid air contamination.In this case, more air bubbles than usual were observed in the aspirated blood.The procedure was completed using the same polarsheath.At the conclusion of the procedure, a coronary angiogram (cag) was performed and confirmed that there was no thrombus formation.

• 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: 13044407
• MDR Text Key: 284008530
• Report Number: 2134265-2021-16049
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0027634031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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