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

Model Number	M00558920
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the papilla during an endoscopic papillary balloon dilatation (epbd) procedure performed for the treatment of common bile duct stone on (b)(6) 2024.During the procedure, an attempt was made to dilate the papilla by performing inflation, the balloon ruptured, and the dilation could not be performed.The procedure was completed with another cre rx dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: the returned cre rx dilatation balloon was analyzed, and a visual inspection found no problem with the device.Functional inspection was performed, the balloon was inflated, and it was able to hold the pressure without any problem.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The device returned has no visible problem, and after a functional inspection the balloon was able to be inflated and maintain its pressure without any problem.Therefore, the most probable root cause is an no problem detected.Block h12 (correction): block g1 (mfr site address 1 and mfr site address 2) have been updated.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the papilla during an endoscopic papillary balloon dilatation (epbd) procedure performed for the treatment of common bile duct stone on (b)(6) 2024.During the procedure, an attempt was made to dilate the papilla by performing inflation, the balloon ruptured, and the dilation could not be performed.The procedure was completed with another cre rx dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19122315
• Report Number: 3005099803-2024-01756
• Device Sequence Number: 7628986
• Product Code: FGE
• UDI-Device Identifier: 08714729965473
• UDI-Public: 08714729965473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172520
• 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
• Report Date (Section B): 06/05/2024

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 Expiration Date: 09/26/2026
• Device Model Number: M00558920
• Device Catalogue Number: 5892
• Device Lot Number: 0032517934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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