MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number	M00558490
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The health care facility is: (b)(6).Phone: (b)(6).Block h6: imdrf device code a0504 captures the reportable event of balloon leaked in the esophagus.
Event or Problem Description
Note: this report pertains to one of four cre wireguided dilatation balloon devices used in the same patient and procedure.It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, it was reported that the balloon leaked when filled with saline.The same issue occurred with the other three cre wireguided dilatation balloons.The procedure was completed with another cre wireguided dilatation balloon device.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of four cre wireguided dilatation balloon devices used in the same patient and procedure.It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, it was reported that the balloon leaked when filled with saline.The same issue occurred with the other three cre wireguided dilatation balloons.The procedure was completed with another cre wireguided dilatation balloon device.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 health care facility is: (b)(6).Block h6: imdrf device code a0504 captures the reportable event of balloon leaked in the esophagus.Block h11: correction: block h10 (the exact facility address and phone number: (b)(6).

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17140087
• Report Number: 3005099803-2023-03196
• Device Sequence Number: 14945479
• Product Code: FDF
• UDI-Device Identifier: 08714729339427
• UDI-Public: 08714729339427
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 02/19/2026
• Device Model Number: M00558490
• Device Catalogue Number: 5849
• Device Lot Number: 0031284988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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