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

Model Number	M00558440
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Imdrf device code a0504 captures the reportable event of balloon leaked in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on an unknown date.During the procedure, the balloon was passed through the scope and positioned in the center of the stricture.When the balloon was inflated, it was noticed that the balloon was not inflating, and the saline was leaking into the patient.The balloon was removed and inspected.It was leaking from where the proximal part of the balloon is joined to the catheter.The procedure was completed with another smaller sized cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophageal dilatation procedure performed on an unknown date.During the procedure, the balloon was passed through the scope and positioned in the center of the stricture.When the balloon was inflated, it was noticed that the balloon was not inflating, and the saline was leaking into the patient.The balloon was removed and inspected.It was leaking from where the proximal part of the balloon is joined to the catheter.The procedure was completed with another smaller sized cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0504 captures the reportable event of balloon leaked in the esophagus.Block h10: investigation results: the returned cre wireguided dilatation balloon was analyzed, and a visual evaluation found no damages were found on to the balloon and catheter of the device.Functional analysis was performed.The balloon was inflated without a problem and held pressure during testing.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was not confirmed.No damages were found on the returned device and the balloon inflated properly during functional testing.There was no evidence of any damages or issues that would indicate a problem with the device.Therefore, the most probable root cause is no problem detected.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 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: 16770434
• Report Number: 3005099803-2023-01949
• Device Sequence Number: 12371314
• Product Code: FDT
• UDI-Device Identifier: 08714729339373
• UDI-Public: 08714729339373
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 09/03/2024
• Device Model Number: M00558440
• Device Catalogue Number: 5844
• Device Lot Number: 0028139906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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