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

Model Number	M00558610
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
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 biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During dilation of the duodenal papilla using cre pro, the balloon burst with fluid outflow when the pressure handle and pressure gauge assembly were used to pressurize and dilate to 1 atm.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.
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 biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During dilation of the duodenal papilla using cre pro, the balloon burst with fluid outflow when the pressure handle and pressure gauge assembly were used to pressurize and dilate to 1 atm.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual evaluation did not identify any physical damages.Functional evaluation found the balloon inflated without any problems however it was not able to hold pressure due to a balloon pinhole located approximately 64 mm from the device tip.The pinhole was confirmed during microscopic inspection.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon burst was not confirmed.The returned device inflated without problems however it was not able to hold pressure due to a pinhole located approximately 64 mm from the device tip.The pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.It is possible that the pinhole found in the balloon occurred due to procedural factors such as excess pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the balloon pinhole.Therefore, the most probable root cause is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21567483
• Report Number: 3005099803-2025-00870
• Device Sequence Number: 9170654
• Product Code: FGE
• UDI-Device Identifier: 08714729797494
• UDI-Public: (01)08714729797494(17)270516(10)34044981
• 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,Followup
• Report Date (Section B): 04/29/2025

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: 0034044981
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 04/06/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG