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

Model Number	M00558600
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital.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 attempted to be used in the bile duct papillary orifice during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2025.During the procedure, pre-expansion of the bile duct papilla was performed, but the balloon was damaged and was leaking the contrast agent.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 facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h2: correction block b5 and h6 device code has been corrected.Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole.
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 bile duct papillary orifice during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2025.During the procedure, pre-expansion of the bile duct papilla was performed, but the balloon was damaged and was leaking the contrast agent.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.Correction was noted on january 02, 2026.It was reported that the damaged noted on the balloon was that there was a small hole on the balloon, through which the liquid was leaking out.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole.Block h11: investigation results.The returned cre pro wireguided dilatation balloon was analyzed, and a visual inspection found no physical damage.A functional evaluation found the balloon inflated without problems but was not able to hold pressure due to a pinhole in the balloon.Microscopic evaluation found the balloon had a pinhole located approximately 43 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon pinhole was confirmed.The returned device was inflated without problems; however, it was not able to hold pressure due to a pinhole located approximately 43 mm from the tip of the device.It is possible that the pinhole found on the balloon occurred due to procedural factors such as excess pressure or interaction with other devices, or anatomical factors.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the pinhole.Therefore, the most probable root cause is adverse event related to procedure.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of balloon pinhole was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
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 bile duct papillary orifice during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2025.During the procedure, pre-expansion of the bile duct papilla was performed, but the balloon was damaged and was leaking the contrast agent.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.Correction was noted on january 02, 2026.It was reported that the damaged noted on the balloon was that there was a small hole on the balloon, through which the liquid was leaking out.

• 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: 23813335
• Report Number: 3005099803-2025-06725
• Device Sequence Number: 18465310
• Product Code: FGE
• UDI-Device Identifier: 08714729797487
• UDI-Public: (01)08714729797487(17)280108(10)35584246
• 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): 03/11/2026

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: M00558600
• Device Catalogue Number: M00558600
• Device Lot Number: 0035584246
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 02/15/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/29/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 62 KG