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

Model Number	M0062201090
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10612372
• Report Number: 3005099803-2020-04302
• Device Sequence Number: 16824140
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1