MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00558420
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	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name: (b)(6).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 wireguided dilatation balloon was used in the orifice of common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the pressure reached 6 atm the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre wireguided dilatation balloon.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.
Additional Manufacturer Narrative
The initial reporter facility name: (b)(6).Imdrf device code a0402 captures the reportable event of a balloon burst.Investigation results: the returned cre wireguided dilatation balloon was analyzed, and a visual examination found that the balloon was damage.Microscopic inspection found that the balloon was burst, and the inside lumen was stretched.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was confirmed.The results of the analysis performed on the returned device found that the balloon was burst.The burst found is likely to have occurred due to procedural factors encountered during the procedure, such as an excess of pressure, the interaction with other devices, or anatomical factors as well.All these factors and interactions could have interfered in the device performance and consequently, on the damage found in the balloon.Also, it is possible that interaction with any kind of sharp surface during the procedure could create friction on the balloon, causing the analyzed problem of the device.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the orifice of common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the pressure reached 6 atm the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre wireguided dilatation balloon.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.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 18448729
• Report Number: 3005099803-2023-06962
• Device Sequence Number: 15209655
• Product Code: FDT
• UDI-Device Identifier: 08714729339359
• UDI-Public: 08714729339359
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110833
• 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): 02/29/2024

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: 05/15/2025
• Device Model Number: M00558420
• Device Catalogue Number: 5842
• Device Lot Number: 0029589973
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG