MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; Catheter, Biliary, Diagnostic

Model Number	M00558710
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pro wireguided dase dilatation balloon was attempted to be used in the esophagus during an esophageal stricture procedure performed on (b)(6) 2026.During the procedure, resistance was encountered when threading the balloon through the working channel of the scope.Upon inflation with the syringe assembly, the balloon burst inside the patients esophagus.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dase dilatation balloon of a different lot number and a non-bsc inflation device.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.Additional information received 03 sep 2026.Patient was having an esophagogastroduodenoscopy (egd) dilation and a cre pro wireguided dilator measurements 18-20mm was used.Instrument appeared intact, all checks completed.The balloon was inflated as normal, but the balloon burst while in the patient's esophagus at the max pressure.No injury to the patient, however, a new instrument had to be used during the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h11: investigation results: the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all available information, boston scientific concludes the reported event of balloon burst could not be confirmed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.A similar complaint review was completed.There were no emerging trends identified that warrant further action.

• Brand Name: CRE PRO
• 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 ; +1(914)571-6918
• MDR Report Key: 50550084
• Report Number: 3005099803-2026-03493
• Device Sequence Number: 10265899
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: (01)08714729797593(17)281113(10)37959117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2026

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: M00558710
• Device Catalogue Number: M00558710
• Device Lot Number: 0037959117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• 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