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

Model Number M0062201070

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Investigation results: visual examination of the returned complaint device found the balloon burst.No more damage found on the device.Functional analysis could not be performed due to the returned condition of the balloon.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose such as; the manner as the device was handled, and/or the interaction with the scope during the procedure.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

Boston scientific corporation received an unauthorized return of an occluder balloon catheter that was used in the kidney during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2019.It was found that the balloon ruptured during the procedure.Reportedly, the procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of the event.The patient condition at the conclusion of the procedure was reported to be good.

• 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: 8920199
• MDR Text Key: 155186899
• Report Number: 3005099803-2019-04147
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 08714729191988
• UDI-Public: 08714729191988
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K133750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2019
• Device Model Number: M0062201070
• Device Catalogue Number: 220-107
• Device Lot Number: 0021676234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• 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
• Patient Age: 40 YR