MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558940
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones on (b)(6) 2025.During the procedure, the balloon popped upon inflation during dilation.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results: the returned cre rx balloon was analyzed, and a visual inspection found that the catheter was kink.Functional inspection found that the device was inflated, and the balloon was able to be inflated without any problem and hold the pressure without any problems.No other problems with the device were noted.With the available information, boston scientific concludes that the reported balloon burst was not confirmed.Analysis of the returned device found a catheter kink, but the balloon inflated and held pressure normally during functional testing.The findings are not consistent with a manufacturing related failure and instead suggest mechanical stress likely related to procedural or operational factors, such as physician manipulation or technique.While a catheter kink was identified, it was not the reported issue and is attributed to process related factors.Therefore, the most probable root cause is device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones on (b)(6) 2025.During the procedure, the balloon popped upon inflation during dilation.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• Brand Name: CRE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; EI 01752 ; 9145716918
• MDR Report Key: 23985137
• Report Number: 3005099803-2026-00067
• Device Sequence Number: 11906747
• Product Code: FGE
• UDI-Device Identifier: 08714729965497
• UDI-Public: (01)08714729965497(17)280616(10)36775398
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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 Model Number: M00558940
• Device Catalogue Number: M00558940
• Device Lot Number: 0036775398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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 Sex: Unknown