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

Model Number	M0062201070
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an occlusion balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated successfully; however, after reaching the required position, it was noticed that the balloon was damaged.A photo sent by the customer cannot confirm on what the damage was noted on the balloon.The procedure was completed with another occlusion balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: medical device code a0203 captures the reportable event of balloon damaged.Block h10: investigation result: a photo was submitted showing the balloon being ruptured and the device complete.A visual examination of the returned complaint device found that the balloon ruptured.The balloon lumen and the distal lumen were in good shape.Functional evaluation was performed through a flushing test and a leak was observed in the ruptured balloon, which confirmed the reported event of balloon damaged.Based on the available information, it is possible that operational factors such as balloon inflation or during the insertion through the scope could have caused the rupture in the balloon.Once the balloon got a rupture a leak could have been present and consequently affect the performance of the device.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 occlusion balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated successfully; however, after reaching the required position, it was noticed that the balloon was damaged.A photo sent by the customer cannot confirm on what the damage was noted on the balloon.The procedure was completed with another occlusion balloon catheter.There were no patient complications reported as a result of this 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: 12459175
• Report Number: 3005099803-2021-04715
• Device Sequence Number: 14469937
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 05/11/2022
• Device Model Number: M0062201070
• Device Catalogue Number: 220-107
• Device Lot Number: 0026488790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR