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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

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

It was reported that during a cryoablation procedure, the polarx balloon catheter could only be inserted into the polarsheath with use of force.At the end of the procedure, right before the fourth of four ablations, the polarsheath started dripping a little (leaking) out of the hemostatic valve of the sheath.The physician reported that the resistance was at the level of the hemostatic valve.The perception was that the extra force needed to get the catheter in, had something to do with the valve and might have contributed to the leak.They decided to proceed and finish the case with the same sheath and catheter.No patient complications occurred.The device is expected to be returned for analysis.

Event Description

It was reported that during a cryoablation procedure, the polarx balloon catheter could only be inserted into the polarsheath with the use of force.At the end of the procedure (right before the fourth of four ablations), a small leak was noted out of the hemostatic valve of the polarsheath.The physician reported that the resistance was at the level of the hemostatic valve.The perception was that the extra force needed to get the catheter inserted was related to the valve and may have contributed to the observed leaking.The physician decided to proceed and finish the case with the same sheath and catheter.No patient complications occurred.The device was returned for analysis.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Initial visual and microscope inspections of the valve revealed a small tear/puncture on the outer section of the valve seal.The device passed initial air pressure testing at 6psi, hemostasis testing at 5.5 psi pressurization with saline, and aspiration testing with a 10 cc and a 60 cc syringe at various flowrates.However, the device did not pass aspiration and hemostasis testing while a polarx test catheter was inserted as well when a dilator was inserted and removed.Dimensional inspection of valve housing from proximal valve end was performed using gauge pins to assess the minor diameter.This location is the minimum pass through point for the dilator and polarx during clinical use.The silicone hemostatic valve component was removed from the sheath prior to gauge pin inspections of the valve housing.The valve housing did not pass the initial diameter tests.Debris on the proximal edge of the valve's diameter was identified during testing; however, it is unknown if the debris was present before testing began.The larger gauge pins were accepted once the debris was removed; however, the valve still did not meet diameter specifications.Further dimensional inspections of valve housing was conducted after additional dissection of the valve was made to further assess the valve housing inner diameter.The dissection and dimensional inspection of the valve housing identified that the inner diameter was below the minimum specification.Laboratory analysis determined that both the tear in the valve seal and the out of specification condition of the valve housing led to the reported clinical observations of a sheath leak and insertion difficulties.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.There is no evidence this device was used in a manner inconsistent with the labeled indications.

• 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: 10521202
• MDR Text Key: 207724454
• Report Number: 2134265-2020-12634
• 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: 12/08/2020

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: 05/13/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025663859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/08/2020
• Patient Sequence Number: 1
• Treatment: POLARX BALLOON CATHETER; POLARX BALLOON CATHETER