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

Model Number	M00558340
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Laceration(s) (1946); Unspecified Tissue Injury (4559)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was attempted to be used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.During the procedure, when the balloon was inflated in the patient's esophagus and moving freely, the balloon popped.It was reported that the balloon was able to be inflated between 8 mm and 9 mm and was able to slide without full distension of the walls of the stenosis and without tension on the balloon.However, when the balloon was attempted to be inflated to 10 mm, the balloon ruptured and leaked sterile water.The procedure was not completed due to this event.A tear of the stenosis was observed.The dilation site was examined and showed moderate mucosal disruption.The patient was sent for an esophagram, admitted to the intensive care unit (icu) at another facility, and transported to a higher level of care.Surgery was not required but the patient was supported with intravenous (iv) fluids and antibiotics.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf patient code e2009 is being used to capture the reportable event of laceration(s).Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Imdrf impact code f0801 is being used to capture the reportable event of intensive care.Imdrf impact code f2304 is being used to capture the reportable event of prophylactic treatment.Imdrf impact code f2203 is being used to capture the reportable event of imaging required.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was attempted to be used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.During the procedure, when the balloon was inflated in the patient's esophagus and moving freely, the balloon popped.It was reported that the balloon was able to be inflated between 8 mm and 9 mm and was able to slide without full distension of the walls of the stenosis and without tension on the balloon.However, when the balloon was attempted to be inflated to 10 mm, the balloon ruptured and leaked sterile water.The procedure was not completed due to this event.A tear of the stenosis was observed.The dilation site was examined and showed moderate mucosal disruption.The patient was sent for an esophagram, admitted to the intensive care unit (icu) at another facility, and transported to a higher level of care.Surgery was not required but the patient was supported with intravenous (iv) fluids and antibiotics.
Additional Manufacturer Narrative
Block a2 (age at time of event), block a3a (sex), block a3b (gender), block a4 (weight), block a5 (ethnicity), block a6 (race) and block h10 (related report number) have been updated.Block h6 (patient codes) has been corrected.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf patient code e2015 is being used to capture the reportable event of unspecified tissue injury.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Imdrf impact code f0801 is being used to capture the reportable event of intensive care.Imdrf impact code f2304 is being used to capture the reportable event of prophylactic treatment.Imdrf impact code f2203 is being used to capture the reportable event of imaging required.

• Brand Name: CRE FIXED WIRE
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21182748
• Report Number: 3005099803-2024-06916
• Device Sequence Number: 8630324
• Product Code: KNQ
• UDI-Device Identifier: 08714729201991
• UDI-Public: 08714729201991
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: M00558340
• Device Catalogue Number: M00558340
• Device Lot Number: 0034135808
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 05/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American