MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number M0062201090

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Investigation results: a visual examination of the returned complaint device found the balloon was burst, thereby the reported event of balloon failure to inflate was confirmed.Microscopic analysis was performed and it was confirmed that the balloon was burst.There were no other damages or issues noted with the device.This failure is likely due to factors or conditions related to procedure, such as the manner in which the device was handled and manipulated, and/or the interaction between the balloon and the scope could possibly have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that an occluder balloon catheter was used in the kidney and ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon would not inflate.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon had burst; therefore, this is now an mdr reportable event.

• Brand Name: OCCLUDER
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10612372
• MDR Text Key: 209364643
• Report Number: 3005099803-2020-04302
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2021
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0025222635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• 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