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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, the balloon was able to be inflated when it was placed in the pelvic ureteric junction; however, the balloon looked deflated after a while, and does not look inflated under the x-ray view.The device was then removed from the patient, and it was confirmed that the balloon burst.The procedure was completed with another occluder balloon catheter.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
Initial reporter address (b)(6).(b)(4).
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6) block h6: medical device code a0402 captures the reportable event of balloon burst.Block h10: investigation result the returned occluder balloon catheter was analyzed, and a visual evaluation noted that the returned balloon and catheter were in good condition.Functional evaluation was performed, and the balloon was able to be inflated without problems.Additionally, the balloon could hold pressure without any evidence of a possible damaged.The balloon was inspected under high magnification, and no problem was found.No problems with the device were noted.The reported event of balloon bursting was not confirmed.No problems were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, the balloon was able to be inflated when it was placed in the pelvic ureteric junction; however, the balloon looked deflated after a while, and does not look inflated under the x-ray view.The device was then removed from the patient, and it was confirmed that the balloon burst.The procedure was completed with another occluder balloon catheter.There were no patient complications reported due to this event.

• Brand Name: OCCLUDER
• Common Device Name: 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: 15638088
• Report Number: 3005099803-2022-05912
• Device Sequence Number: 5677975
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 07/18/2023
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0028875204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian