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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL
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BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL Back to Search Results
Model Number M0062251020
Medical Device Problem Code Burst Container or Vessel (1074)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/08/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used during a procedure performed on (b)(6) 2020.During the procedure, it was noted that the balloon ruptured.There were no patient complications reported as result of this event.
 
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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 Key12276984
Report Number3005099803-2021-03988
Device Sequence Number3612493
Product Code EZN
UDI-Device Identifier08714729341123
UDI-Public08714729341123
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K130804
Number of Events Summarized1
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) 08/04/2021
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 Date06/04/2022
Device Model NumberM0062251020
Device Catalogue Number225-102
Device Lot Number0023904889
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date08/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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