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

Model Number	M00558700
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of balloon deformed.
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 stricture dilatation procedure performed on (b)(6) 2026.During the procedure, the balloon was not pretested as requested by the physician; however, it was advanced through the biopsy cap and navigated through the enteroscope working channel without difficulty.The procedure progressed normally, and the balloon functioned as intended during dilation.When withdrawal was attempted, the balloon could not be retrieved through the enteroscope and was noted to be deformed.All standard troubleshooting steps were performed to confirm complete deflation, but removal through the scope remained unsuccessful.Despite these efforts, the physician continued to encounter difficulty retrieving the cre catheter.Ultimately, the tip of the balloon was cut, allowing successful removal of the catheter from the scope.A photo was provided by the customer and showed that the balloon was deformed.The procedure was completed with another cre pro wireguided dilatation balloon.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of balloon deformed.Block h11: investigation results the device was not returned for analysis; however, media analysis shows that the balloon detachment was observed.Device history records review: 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.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 stricture dilatation procedure performed on (b)(6) 2026.During the procedure, the balloon was not pretested as requested by the physician; however, it was advanced through the biopsy cap and navigated through the enteroscope working channel without difficulty.The procedure progressed normally, and the balloon functioned as intended during dilation.When withdrawal was attempted, the balloon could not be retrieved through the enteroscope and was noted to be deformed.All standard troubleshooting steps were performed to confirm complete deflation, but removal through the scope remained unsuccessful.Despite these efforts, the physician continued to encounter difficulty retrieving the cre catheter.Ultimately, the tip of the balloon was cut, allowing successful removal of the catheter from the scope.A photo was provided by the customer and showed that the balloon was deformed.The procedure was completed with another cre pro wireguided dilatation balloon.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• 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: 24438553
• Report Number: 3005099803-2026-00723
• Device Sequence Number: 10372597
• Product Code: FGE
• UDI-Device Identifier: 08714729797586
• UDI-Public: (01)08714729797586(17)280831(10)37340980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 03/24/2026

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: M00558700
• Device Catalogue Number: M00558700
• Device Lot Number: 0037340980
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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