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

Model Number	M00558350
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wired dilatation balloon was used during a procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon popped during inflation.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wired dilatation balloon was used during a procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon popped during inflation.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon was torn longitudinally and circumferentially.The catheter of the device was bent located approximately 67cm from the hub.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The longitudinal and circumferential tears found could have been interpreted by the customer as the reported event of balloon burst.The tears in the balloon are likely to have occurred due to factors encountered during the procedure, such as excess pressure, interaction with other devices, or anatomical factors.It is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon, causing a longitudinal and circumferential tear.Demonstrating excessive force during handling or usage and/or forcing the device against significant resistance could result in device damage or loss of functionality.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15877445
• Report Number: 3005099803-2022-06928
• Device Sequence Number: 20195342
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: 08714729202004
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K971320
• 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,Followup
• Report Date (Section B): 12/29/2022

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: 06/06/2024
• Device Model Number: M00558350
• Device Catalogue Number: 5835
• Device Lot Number: 0029545939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown