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

Model Number	M00558610
Medical Device Problem Codes	Inflation Problem (1310); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name is the (b)(6) hospital (b)(6); reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a0414 captures the reportable investigation finding of balloon torn.Block h11: investigation results.The returned cre pro wireguided dase dilatation balloon device was analyzed, and a visual inspection found no damages.A functional inspection was performed, and the balloon was inflated without any problem, however, it was not able to hold the pressure due to it was teared.Microscope inspection confirmed the presence of a tear.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon failure to inflate can be confirmed.The results of the analysis performed on the returned device found that the device was inflated without any problem, however, it was not able to hold the pressure due to a tear which result in the reported failure to inflate.The teared found in the balloon is likely to have occurred due to factors encountered during the procedure or it can be due to excess pressure.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during/previous the procedure could create friction on the balloon, causing the problem of teared during the procedure.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was attempted to be used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure for common bile duct stone performed on (b)(6) 2026.During the procedure, the balloon could not be inflated after entering the designated position along the guidewire.The procedure was completed with another of the same device.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 stable.This event has been deemed a reportable event based on the investigation finding of balloon tear.Please see block h11 for full investigation details.

• 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: 25295497
• Report Number: 3005099803-2026-02123
• Device Sequence Number: 9294442
• Product Code: FGE
• UDI-Device Identifier: 08714729797494
• UDI-Public: (01)08714729797494(17)280205(10)35785307
• 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
• Report Date (Section B): 05/26/2026

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: M00558610
• Device Catalogue Number: M00558610
• Device Lot Number: 0035785307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 50 KG