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

Model Number	M0062201090
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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 (pnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon was leaking due to a hole in the balloon material.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1504 captures the reportable issue of balloon hole.A visual examination of the returned complaint device found that the balloon was noted to be burst.No damages were found on the catheter of the device.Functional analysis could not be performed due to the condition of the returned device.This failure is likely due to factors or conditions related to procedure such as handling of the device, the technique used by the physician during the procedure, the amount of strength applied by the physician during the movement of the balloon, and/or the interaction between the scope and the balloon could have caused the reported event, leading the balloon to burst.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 during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon was leaking due to a hole in the balloon material.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: block h6: problem code 1504 captures the reportable issue of balloon hole.Block h10: a visual examination of the returned complaint device found that the balloon was noted to be burst.No damages were found on the catheter of the device.Functional analysis could not be performed due to the condition of the returned device.This failure is likely due to factors or conditions related to procedure such as handling of the device, the technique used by the physician during the procedure, the amount of strength applied by the physician during the movement of the balloon, and/or the interaction between the scope and the balloon could have caused the reported event, leading the balloon to burst.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 directions for use (dfu)/product label.
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 (pnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon was leaking due to a hole in the balloon material.The procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this 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: 9779312
• Report Number: 3005099803-2020-00700
• Device Sequence Number: 2787503
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup,Followup
• Report Date (Section B): 09/22/2020

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: 09/14/2020
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0023644573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 09/01/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 05/05/2020; 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1