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

Lot Number 0029661257

Device Problems Use of Device Problem (1670); Air/Gas in Device (4062)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

It was reported that during a cryo-ablation procedure using a polar sheath air was see in the sheath's side port after aspirating with the balloon catheter inside of the sheath.They replaced the sheath and repeated the aspiration with the balloon catheter inside the second sheath, air was once again observed.They then removed the catheter and re-inserted the catheter without applying the negative pressure and no air was observed in the sheath.The procedure was completed with the original catheter and the second sheath with no patient complications.At no point was any air seen in the patient.The sheath is expected to be returned for analysis.

Event Description

It was reported that during a cryo-ablation procedure using a polarsheath air was see in the sheath's side port after aspirating with the balloon catheter inside of the sheath.They replaced the sheath and repeated the aspiration with the balloon catheter inside the second sheath, air was once again observed.They then removed the catheter and re-inserted the catheter without applying the negative pressure and no air was observed in the sheath.The procedure was completed with the original catheter and the second sheath with no patient complications.At no point was any air seen in the patient.The sheath has been returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the sheath was first visually inspected, and no visual abnormalities were found.Next, they functionally tested the sheath by replicating aspiration and the sheath was within specification and showed no air bubbles for each variation of the test.Then, they tested the integrity of the hemostatic valve and found the sheath was within specification for maintaining internal pressure and no leaks were observed.Based on all the available evidence the conclusion is that no problem was detected with the returned device, the reported allegation of air in the device could not be replicated, and no other issues were found with the device.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The ifu states "do not aspirate via the side port if the sheath lumen is occupied (i.E., by the dilator or components of the cryoablation catheter) as the aspiration may draw air across the sheath valve into the polarsheath.", as investigation found no defect with the device, if any air was seen in the sheath the most likely cause would have been use of the device that was contradictory to the provided instructions.

• 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: 15839666
• MDR Text Key: 307563859
• Report Number: 2124215-2022-47712
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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: 05/08/2023
• Device Lot Number: 0029661257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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
• Treatment: POLARSHEATH; POLARSHEATH