MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE RX; Catheter, Biliary, Diagnostic

Model Number	M00558880
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the esophagus, gastric, and duodenum during an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2026.During the procedure, the black outer catheter was detached and left in the scope channel.Subsequently, it was pushed into the patient and was successfully retrieved using a rescue forceps.The device was removed and the procedure was completed cre rx biliary dilatation balloon.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 be stable.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, 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 h2: block h1 (type of reportable event) has been corrected.Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Imdrf impact code f2301 is being used to capture the reportable event of additional device required (rescue forceps).Block h11: investigation results: the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.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 similar complaint review was completed.There were no emerging trends identified that warrant further action.

• Brand Name: CRE RX
• 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 ; +1(914)571-6918
• MDR Report Key: 50623626
• Report Number: 3005099803-2026-03644
• Device Sequence Number: 13402763
• Product Code: FGE
• UDI-Device Identifier: 08714729965435
• UDI-Public: (01)08714729965435
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558880
• Device Catalogue Number: M00558880
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown