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

Model Number	M00558480
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was being prepared for use in a procedure performed on (b)(6) 2023.During preparation, the technician found a hole in the balloon upon attempted inflation prior to inserting the balloon in the patient.The procedure was completed with another re wireguided dilatation balloon.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.
Additional Manufacturer Narrative
Block e1: this event was reported by the (b)(6).The healthcare facility is: (b)(6) hospital (b)(6).Phone number: (b)(6).Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in an unknown anatomy location.

• 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: 18242234
• Report Number: 3005099803-2023-06424
• Device Sequence Number: 6581908
• Product Code: FDT
• UDI-Device Identifier: 08714729339410
• UDI-Public: 08714729339410
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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: 08/05/2026
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 0032356376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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