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

Model Number	M00558490
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
Note: this report pertains to one of two cre wireguided dilatation balloon used in the same patient and procedure.It was reported to boston scientific corporation that a cre wireguided dilatation balloon was being prepared for use in the esophagus during an esophagogastroduodenoscopy (egd) procedure to be performed on (b)(6) 2024.During preparation, the balloon burst before they could fully inflate the balloon.It was reported that it happened with 2 balloons from the same lot.The procedure was completed.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.

• Brand Name: CRE WIREGUIDED
• Common Device Name: COLONOSCOPE 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: 20928632
• Report Number: 3005099803-2024-06298
• Device Sequence Number: 12842023
• Product Code: FDF
• UDI-Device Identifier: 08714729339427
• UDI-Public: 08714729339427
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: M00558490
• Device Catalogue Number: M00558490
• Device Lot Number: 0034461408
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 07/18/2024
• 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