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

Model Number	M00558630
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat jaundice performed on (b)(6) 2025.During the procedure, after the balloon was slowly pressurized, it was found that the balloon was ruptured 3 atm (12 mm).It was reported that no piece of the balloon detached inside the patient.Additionally, a photo of the complaint device was provided and showed an inflated balloon with irregular shape.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 at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is first affiliated hospital of (b)(6).Reported here as the initial reporter facility name exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.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 in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat jaundice performed on (b)(6) 2025.During the procedure, after the balloon was slowly pressurized, it was found that the balloon was ruptured 3 atm (12 mm).It was reported that no piece of the balloon detached inside the patient.Additionally, a photo of the complaint device was provided and showed an inflated balloon with irregular shape.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 at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is first affiliated hospital of zhejiang university school of medicine; reported here as the initial reporter facility name exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a0406 captures the reportable event of balloon deformed.Block h11: investigation results the cre pro wireguided dilatation balloon device was not returned; however, a media analysis was performed based on the photo provided by the complainant that shows the inflated balloon with irregular shape.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon irregular shape was confirmed.According to the media analysis performed, it was found that the balloon exhibited an irregular shape.This condition is likely attributable to procedural factors, such as excessive pressure, interaction with other devices, or possible contact with a sharp surface during or prior to the procedure.On the other hand, the reported event of balloon burst could not be confirmed.Although the irregular balloon shape suggests the possibility of damage, the available evidence does not confirm the burst.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6); reported here as the initial reporter facility name exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a0406 captures the reportable event of balloon deformed.Block h11: investigation results.The returned cre pro wireguided dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was inflated without any problem; however, it was not able to hold the pressure due to it had a pinhole in the balloon, located approximately at 10 mm from the tip of the device, and the balloon with irregular shape was found.Media analysis was performed based on the photo provided by the complainant that shows the inflated balloon with irregular shape.Microscopic inspection confirmed the balloon pinhole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon irregular shape was confirmed.The results of the analysis performed on the returned device found that the balloon exhibited an irregular shape.This condition is likely attributable to procedural factors, such as excessive pressure, interaction with other devices, or possible contact with a sharp surface during or prior to the procedure.On the other hand, the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.Although the irregular balloon shape suggests the possibility of damage, the available evidence does not confirm the burst.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.
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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat jaundice performed on (b)(6) 2025.During the procedure, after the balloon was slowly pressurized, it was found that the balloon was ruptured 3 atm (12 mm).It was reported that no piece of the balloon detached inside the patient.Additionally, a photo of the complaint device was provided and showed an inflated balloon with irregular shape.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 at the conclusion of the procedure was reported to be stable.

• 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: 23708729
• Report Number: 3005099803-2025-06570
• Device Sequence Number: 18803929
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: (01)08714729797517(17)270128(10)33308659
• 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,Followup
• Report Date (Section B): 02/24/2026

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: M00558630
• Device Catalogue Number: M00558630
• Device Lot Number: 0033308659
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 02/03/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/06/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 69 KG