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

Model Number	M0062201070
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8920199
• Report Number: 3005099803-2019-04147
• Device Sequence Number: 13929099
• Product Code: EYB
• UDI-Device Identifier: 08714729191988
• UDI-Public: 08714729191988
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: 07/02/2019
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR