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

Model Number	M00558620
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to a jagwire revolution, truetome 39, two trapezoid rx lithotripter baskets, and cre pro wireguided dilatation balloon used during the same procedure.It was reported to boston scientific corporation that a jagwire revolution, truetome 39, two trapezoid rx lithotripter baskets, and cre pro wireguided dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) and cbd stone removal procedure to treat jaundice and cbd stone performed on march 23, 2026.During the procedure, after the stone was captured, the basket could not be pulled through the papilla.The trapezoid rx basket was then connected to an alliance handle to perform lithotripsy.During lithotripsy, the basket fractured at the handle end, and the safety release mechanism did not activate to allow release of the stone from the basket.The physician then performed another cre dilation, but the cre balloon developed a small rupture during inflation.Following the rupture of the cre balloon, the physician attempted a partial papillotomy using a truetome.However, the cutting efficiency was poor, possibly due to interference from a cbd stone or the trapezoid basket wire.Additionally, the rotatable tip function of the truetome failed to operate as expected.A second trapezoid rx basket was used; however, this basket handle also fractured during lithotripsy.During the process, the guidewire coating peeled off, so a new guidewire was used.As a result, the basket with the impacted stone was left in the patient, and the procedure was discontinued and rescheduled for the following day.On the next day, the procedure was successfully completed using spyglass and an ehl probe to perform lithotripsy and remove the stone.No patient complications were reported as a result of this event.The patient's condition was reported as fine following the successful completion of the rescheduled procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf impact code f1001 captures the reportable event of aborted procedure.

• 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: 24918058
• Report Number: 3005099803-2026-01432
• Device Sequence Number: 15947727
• Product Code: FGE
• UDI-Device Identifier: 08714729797500
• UDI-Public: (01)08714729797500(17)280822(10)37278679
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: M00558620
• Device Catalogue Number: M00558620
• Device Lot Number: 0037278679
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 08/23/2025
• 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