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

Lot Number 0028821163

Device Problem Material Integrity Problem (2978)

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

Event Date 06/24/2022

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 in the latter part of a cryoablation procedure, the polarsheath's hemostatic valve was broken when the balloon catheter was removed from the patient.Resistance was felt near the hemostatic valve when the balloon catheter was removed.This sheath was removed from the patient and the procedure was successfully completed without any patient complications.This polarsheath is expected to be returned for laboratory analysis.

Manufacturer Narrative

The device has been received for analysis.Visual inspection revealed that the hemostatic valve was compromised, an uncontrolled tear was observed on the valve.Hemostasis and air pressure testing was conducted, and the sheath met all specifications with no signs of leaking or disruption of pressure.Laboratory analysis was able to confirm the reported clinical observations.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

It was reported that in the latter part of a cryoablation procedure, the polarsheath's hemostatic valve was broken when the balloon catheter was removed from the patient.Resistance was felt near the hemostatic valve when the balloon catheter was removed.This sheath was removed from the patient and the procedure was successfully completed without any patient complications.This polarsheath has been returned for laboratory analysis.

• 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: 15016006
• MDR Text Key: 295957207
• Report Number: 2134265-2022-07901
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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: 0028821163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• 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
• Patient Sequence Number: 1