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

Model Number	M0062201100
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned complaint device found that the balloon, distal tip and hub were in a good condition.There were no kinks, clamp marks or elongation noted on the balloon.Functional evaluation was performed, and the balloon was inflated; however, it was noticed that the balloon had a pinhole.The found failure of a pinhole confirms the reported event of the balloon leaking.This failure is likely that the pinhole is the result of device manipulation while the device had been prepared or an extra force could have been applied on it causing the pinhole and consequently the leak that was being reported.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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used during a percutaneous nephrolithotomy (pnl) procedure to be used in the ureter/kidney performed on (b)(6) 2021.During preparation, the balloon was noted to be leaking while the contrast with nacl was being inserted without inflating the balloon.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 this balloon has a pinhole; 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: 12045715
• Report Number: 3005099803-2021-03021
• Device Sequence Number: 16368176
• Product Code: EYB
• UDI-Device Identifier: 08714729161691
• UDI-Public: 08714729161691
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 03/21/2022
• Device Model Number: M0062201100
• Device Catalogue Number: 220-110
• Device Lot Number: 0026206686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1