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

Model Number	M00558680
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a040101 captures the reportable event of a balloon failure to deflate.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during an esophageal dilation to treat esophageal stenosis performed on (b)(6) 2026.During the procedure, the dilation balloon ruptured during esophageal dilation.They were not able to easily deflate and pull out the balloon, so they had to cut the catheter of the balloon for it to be loose enough for removal.No piece of the device was detached inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition was expected to fully be recovered.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during an esophageal dilation to treat esophageal stenosis performed on (b)(6) 2026.During the procedure, the dilation balloon ruptured during esophageal dilation.They were not able to easily deflate and pull out the balloon, so they had to cut the catheter of the balloon for it to be loose enough for removal.No piece of the device was detached inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition was expected to fully be recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a040101 captures the reportable event of a balloon failure to deflate.Block h11: the returned cre pro wireguided dilatation balloon was analyzed, and visual inspection found a mechanical cut along the catheter, affecting a portion of the catheter and the entire balloon section.A segment of the material was found to be detached and was not returned with the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst and balloon failure to deflate was not confirmed.Analysis of the returned device revealed that the device exhibited a mechanical cut along the catheter affecting the balloon segment and with a portion of the material not returned.Therefore, functional testing could not be performed.The catheter detachment corresponds to an intentional action performed by the physician during the procedure, specifically cutting the catheter as a measure to facilitate device removal in response to the encountered difficulty.Based on all gathered information and the analysis performed, the most probable cause of this complaint is cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformance's, 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.

• 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: 24423725
• Report Number: 3005099803-2026-00687
• Device Sequence Number: 21477078
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: (01)08714729797562(17)280311(10)36049395
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 04/23/2026

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: 0036049395
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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 Sex: Unknown