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

Model Number	M00558650
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used during a procedure performed on an unknown date.It was reported that there was a hole in the balloon.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in the esophagus.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 85 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific (bsc) 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 85 mm from the tip of the device.It is possible that the pinhole found in the balloon occurred due to procedural factors such as excess of pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during/previous the procedure, could have caused the problem found on the balloon.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used during a procedure performed on an unknown date.It was reported that there was a hole in the balloon.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.

• 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: 23845770
• Report Number: 3005099803-2025-06795
• Device Sequence Number: 9958625
• Product Code: FGE
• UDI-Device Identifier: 08714729797531
• UDI-Public: (01)08714729797531(17)280702(10)36893754
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: M00558650
• Device Catalogue Number: M00558650
• Device Lot Number: 0036893754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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 Sex: Unknown