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

Model Number	M00558600
Medical Device Problem Codes	Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of balloon torn.Block e1: initial reporter facility name is (b)(6) hospital of (b)(6); reported here as the facility name exceeded character limit for designated field.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was attempted to be used in the bile duct papillary orifice during an endoscopic retrograde cholangiopancreatography (ercp) procedure for pancreatic duct stones performed on (b)(6) 2026.During unpacking, the physician observed a slight crack in the balloon prior to use.Despite this observation, the balloon was introduced into the patients body.During procedure, the balloon fractured into two separate sections during inflation and pressurization.No piece of balloon detached inside the patient.The procedure was completed with a different device.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.The instructions for use (ifu) indicate that this balloon should not be used if material damage is found prior to its use.However, the customer reported that the balloon was found damaged during unpacking.

• 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: 25023830
• Report Number: 3005099803-2026-01561
• Device Sequence Number: 10127231
• Product Code: FGE
• UDI-Device Identifier: 08714729797487
• UDI-Public: (01)08714729797487(17)280429(10)36409518
• 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): 07/17/2026

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: 0036409518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 05/05/2026; 06/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/27/2026; 07/17/2026
• Date Device Manufactured: 04/30/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 63 KG