MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL

Model Number	M0062251020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 a uromax ultra dilation balloon catheter was used in the ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2020.During preparation, the balloon was tested by inflating water into it and it was noted that the balloon was leaking and can not be inflated.The procedure was completed with another uromax ultra dilation 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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter was used in the ureter during a flexible ureteroscopy (furs) procedure performed on december 31, 2020.During preparation, the balloon was tested by inflating water into it and it was noted that the balloon was leaking and can not be inflated.The procedure was completed with another uromax ultra dilation 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 stable.
Additional Manufacturer Narrative
Block h6: problem code a0504 captures the reportable event of balloon leak.Block h10: investigation result: a visual examination of the complaint device revealed that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a longitudinal tear in the balloon.No issues were noted on the balloon material, markerbands and tip.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.This failure is likely due to an interaction between the user and device, or sample, that caused or contributed to the error.It is likely that the failure may be related to unintended inappropriate use of the device and incorrect sample preparation.Therefore, the most probable root cause is unintended use error caused or contributed to event.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.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11463092
• Report Number: 3005099803-2021-01042
• Device Sequence Number: 14500614
• Product Code: EZN
• UDI-Device Identifier: 08714729341123
• UDI-Public: 08714729341123
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130804
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 03/09/2023
• Device Model Number: M0062251020
• Device Catalogue Number: 225-102
• Device Lot Number: 0025327532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1