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

Model Number	M00558630
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two cre pro wireguided dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during a procedure performed on (b)(6) 2024.During the procedure, while inflating the balloon inside the patient's esophagus, the balloon burst.The same problem occurred with the second cre pro wireguided dilatation balloon.The procedure was completed with a third cre pro wireguided dilatation balloon.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

• Brand Name: CRE PRO
• 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: 19935212
• Report Number: 3005099803-2024-03733
• Device Sequence Number: 15311680
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: 08714729797517
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: M00558630
• Device Catalogue Number: 5863
• Device Lot Number: 0034044986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/07/2024
• Date Device Manufactured: 05/16/2024
• 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