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

Model Number	M00558680
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus, as the anatomy is unknown.Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.Because the product was not returned, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.Block h11: investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.A product labeling review identified that the device was used per the instruction for use (ifu) / product label.A risk review was completed and confirmed that the event of balloon leak was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used during a dilation procedure performed on an unknown date.During the procedure, there was a pressure loss, and the balloon could not be inflated to 4.5 atm.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.The anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used during a dilation procedure performed on an unknown date.During the procedure, there was a pressure loss, and the balloon could not be inflated to 4.5 atm.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.The anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus, as the anatomy is unknown.Block d4, h4: (additional information).Block h11: investigation results the device has been received for analysis; however, the analysis is still in progress.A report will be submitted with the investigation results after the investigation has been completed.A review of the manufacturing documentation for this device was unable to be performed as the lot number was unknown.However, a ship history review was performed to identify the most probable lots, and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.A product labeling review identified that the device was used per the instruction for use (ifu) / product label.A risk review was completed and confirmed that the event of balloon leak was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.

• 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: 24592431
• Report Number: 3005099803-2026-00943
• Device Sequence Number: 12995046
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: (01)08714729797562(17)281123(10)38031623
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: M00558680
• Device Catalogue Number: M00558680
• Device Lot Number: 0038031623
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 04/24/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/15/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2025
• 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