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

Model Number	M00558620
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was being prepared to be used the pylorus during an endoscopic balloon dilatation procedure for benign pyloric stenosis performed on (b)(6) 2026.During preparation outside the patient, the balloon ruptured.The procedure was completed with cre pro wireguided dase dilatation balloon.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.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was being prepared to be used the pylorus during an endoscopic balloon dilatation procedure for benign pyloric stenosis performed on (b)(6) 2026.During preparation outside the patient, the balloon ruptured.The procedure was completed with cre pro wireguided dase dilatation balloon.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.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst block h11: investigation result the device was not returned for analysis despite good faith efforts to obtain product return; 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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.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: 25791410
• Report Number: 3005099803-2026-02771
• Device Sequence Number: 5953302
• Product Code: FGE
• UDI-Device Identifier: 08714729797500
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: M00558620
• Device Catalogue Number: M00558620
• Device Lot Number: 0035839500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/12/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/12/2025
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 162 LB