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

Model Number	M00558690
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
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 a0414 captures the reportable investigation results of balloon torn longitudinal.Block h11: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual and microscopic evaluation found the balloon had a longitudinal tear.No other problems with the device were noted.The returned device had a longitudinal tear.It is likely to have occurred due to factors encountered during the procedure, it can be due as excess pressure, interaction with other devices, or anatomical factors.Also, it is possible that interaction with any kind of sharp surface during/previous to the procedure could create friction on the balloon, causing the longitudinal tear during the procedure.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 attempted to be used in the papilla during a papillary dilatation procedure performed on an unknown date.During the procedure, when trying to inflate the balloon, it did not inflate.When it was checked outside the patient it was confirmed that there was a hole in the balloon.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a balloon torn longitudinal.Please see block h11 for full investigation details.

• 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: 21862988
• Report Number: 3005099803-2025-01619
• Device Sequence Number: 14604059
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: (01)08714729797579(17)261203(10)32977357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/18/2025

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: M00558690
• Device Catalogue Number: M00558690
• Device Lot Number: 0032977357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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