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

Model Number	M00558650
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital (b)(6) reported here as the facility name exceeded the character limit for the designated field.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 pro wireguided dilatation balloon was used in the duodenal bulb descending junction during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat the cholangitis performed on (b)(6) 2025.During the procedure, the dilation balloon was advanced along the guidewire to gradually dilate the stenosis.It was reported that the balloon burst at 5 atm, but no piece of the balloon detached inside the patient.After the balloon was burst, the patient gastric mucosa was torn, resulting in bleeding.The bleeding was treated with fasting, hemostatic drugs, somatostatin, and other conservative measures.The procedure was completed with another cre pro wireguided dilatation balloon device.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results.The cre wireguided dilatation balloon device was not returned for analysis, and a media inspection observed that the balloon with evidence of torn longitudinal.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.There is insufficient evidence to determine whether the longitudinal tear resulted from physician manipulation/technique during the procedure or from a potential device malfunction.Due to the lack of evidence and the absence of a direct device evaluation, this investigation is assigned a most probable conclusion code of unable to exclude device problem.This conclusion is appropriate because the analysis of the available complaint information did not identify a more specific root cause.Furthermore, without the device for proper evaluation, the most probable contributing factors remain unknown.The product record review also did not identify any potential product quality issues or new patient harm.Based on all compiled information, the most probable cause is therefore classified as unable to exclude device problem.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the duodenal bulb descending junction during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat the cholangitis performed on (b)(6) 2025.During the procedure, the dilation balloon was advanced along the guidewire to gradually dilate the stenosis.It was reported that the balloon burst at 5 atm, but no piece of the balloon detached inside the patient.After the balloon was burst, the patient gastric mucosa was torn, resulting in bleeding.The bleeding was treated with fasting, hemostatic drugs, somatostatin, and other conservative measures.The procedure was completed with another cre pro wireguided dilatation balloon device.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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 ; 9145716918
• MDR Report Key: 24127256
• Report Number: 3005099803-2026-00261
• Device Sequence Number: 13360683
• Product Code: FGE
• UDI-Device Identifier: 08714729797531
• UDI-Public: (01)08714729797531(17)271113(10)35273052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/02/2026

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: M00558650
• Device Catalogue Number: M00558650
• Device Lot Number: 0035273052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG