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

Lot Number 0028821162

Device Problem Leak/Splash (1354)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath blood leaked from the hemostatic valve.The leak was characterized as a slow drip and no air was seen in the sheath or the patient.They exchanged the sheath and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Event Description

It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath blood leaked from the hemostatic valve.The leak was characterized as a slow drip and no air was seen in the sheath or the patient.They exchanged the sheath and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory the sheath was first visually inspected which found nothing abnormal.Next, the sheath was put through procedural testing by replicating aspiration.The sheath failed this aspiration test as air was visible in the flushing line each time the syringe was drawn.The next procedural test examined the hemostatic valve, which found the sheath was not able to maintain pressure even when there was nothing across the valve.Finally, they gently pressurized the sheath, while the distal tip was plugged, and the pressure decay value indicated a gross leak of the hemostatic valve.With all the available information boston scientific concludes the allegation of "air observed in the sheath" is confirmed.The kind of leak seen in the testing can lead to air being observed in the sheath during use.

• 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: 15550467
• MDR Text Key: 305370549
• Report Number: 2124215-2022-40028
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Lot Number: 0028821162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92688876-FA
• Patient Sequence Number: 1