MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE

Lot Number 0029918145

Device Problems Device Contamination with Body Fluid (2317); Material Integrity Problem (2978)

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

Event Date 02/13/2023

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

During procedure, a polarsheath was selected for use.It was reported that after the 4th pulmonary vein isolation for atrial fibrillation ablation, blood leakage was confirmed during roof ablation, and a hemostatic valve malfunction was suspected.Sheath was replaced and procedure completed successfully.No patient complications reported.Product is expected to be returned.

Event Description

During procedure, a polarsheath was selected for use.It was reported that after the 4th pulmonary vein isolation for atrial fibrillation ablation, blood leakage was confirmed during roof ablation, and a hemostatic valve malfunction was suspected.Sheath was replaced and procedure completed successfully.No patient complications reported.Product has been returned for analysis.

Manufacturer Narrative

Product was returned and analyzed.The reported complaint was confirmed.Visual inspection was performed, and the hemostatic valve was found to have a large tear which was visible under microscopy.The device failed all functional testing performed and air bubbles were visible in the flushing line during test/syringe vacuum.Hemostasis valve test method failed, and the sheath was not able to maintain a minimum pressure of 5.5 psi.Air pressure test for location of leaks was also performed and the device was gently pressurized with 6 psi at the flushing line lure fitting while plugging the distal tip of the sheath.The pressure decay value passed.In conclusion-analysis found that the allegation was confirmed.There was a tear in the hemostatic valve which could lead to the polarsheath leaking.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 16537176
• MDR Text Key: 311241038
• Report Number: 2124215-2023-07821
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2023
• Device Lot Number: 0029918145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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