MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558600
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a04 captures the reportable event of balloon damaged.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the bile duct papillary opening during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2025.During the procedure, a pre dilation on the papillary opening of the bile duct was performed and it was noted that the balloon was damaged, and the contrast medium leaked during dilatation.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 at the conclusion of the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.Based on the event that the balloon was damaged, the reported event may suggest that the balloon might be burst.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a04 captures the reportable event of balloon damaged.Block h11: (investigation result) the returned cre pro wireguided dilatation balloon was analyzed, and a visual and microscopic evaluation noted no problem with the device.Functional inspection also reveals that the balloon was able to be inflated and hold pressure.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon damaged was not confirmed.The returned device is in good condition and capable of being inflated and can hold pressure without any evidence of leak.Based on the investigation findings and all gathered information, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the bile duct papillary opening during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2025.During the procedure, a pre dilation on the papillary opening of the bile duct was performed and it was noted that the balloon was damaged, and the contrast medium leaked during dilatation.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 at the conclusion of the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.Based on the event that the balloon was damaged, the reported event may suggest that the balloon might be burst.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• 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: 22861983
• Report Number: 3005099803-2025-04224
• Device Sequence Number: 9359626
• Product Code: FGE
• UDI-Device Identifier: 08714729797487
• UDI-Public: (01)08714729797487(17)271009(10)35027782
• 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): 10/21/2025

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: M00558600
• Device Catalogue Number: M00558600
• Device Lot Number: 0035027782
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG