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

Model Number	M00558400
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	06/18/2024
Type of Reportable Event	Malfunction
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 wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the balloon burst at 9mm.It was reported that no piece of the balloon was detach 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 and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual examination found that the balloon had no damage.Functional analysis was performed, and the balloon would not hold pressure due to pinhole in the tip section.Microscopic inspection found a pinhole located approximately at 50mm from the tip of the balloon.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst cannot be confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.The pinhole found in the balloon is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during/previous the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is 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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the balloon burst.It was reported that no piece of the balloon was detach 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 and 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: 19720763
• Report Number: 3005099803-2024-03319
• Device Sequence Number: 12813664
• Product Code: FDT
• UDI-Device Identifier: 08714729339335
• UDI-Public: 08714729339335
• 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): 09/25/2024

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: 04/16/2025
• Device Model Number: M00558400
• Device Catalogue Number: 5840
• Device Lot Number: 0029415648
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 71 KG