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

Model Number	M00558930
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
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 duodenal papilla during a papillary dilation procedure performed on (b)(6) 2024.During the ongoing use of the device, the balloon ruptured at 3 atm (10 mm).The customer reported that no piece of the balloon detached inside the patient.The procedure was completed using the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the duodenal papilla during a papillary dilation procedure performed on october 18, 2024.During the ongoing use of the device, the balloon ruptured at 3 atm (10 mm).The customer reported that no piece of the balloon detached inside the patient.The procedure was completed using the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.H11: investigation results the returned cre rx dilatation balloon was analyzed, and a visual inspection found no damage to the device.Functional and microscopic inspection found a pinhole approximately 50 mm from the device tip (which led to the reported leak).No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The results of the analysis performed on the returned device found that a balloon pinhole is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during or prior to the procedure could create friction on the balloon, causing the problem of pinhole during the procedure.Therefore, the most probable root cause is an adverse event related to procedure.

• 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 CORK LIMITED; 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: 20669026
• Report Number: 3005099803-2024-05626
• Device Sequence Number: 12572532
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: 08714729965480
• 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): 12/12/2024

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 Model Number: M00558930
• Device Catalogue Number: M00558930
• Device Lot Number: 0034508031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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