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

Model Number	M00567420
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in good condition, thereby the reported event of balloon bursting was not confirmed.The catheter of the device was carefully inspected and was found to be detached from the hub section; the hub section was not returned with the device.This failure is likely due to factors encountered during the procedure, such as the technique used by the physician and/or the interaction between the balloon with the scope during the procedure, that could have caused the physician to feel some resistance, leading to the detachment of the device; this could have possibly been perceived by the physician as the balloon bursting during the procedure.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instruction for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used during a duodenal papilla dilation procedure performed on (b)(6) 2021.During the procedure, the device was difficult to maintain in the scope and the balloon eventually ruptured when inflated to less than 12 atm.The procedure was completed with another maxforce biliary dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: MAXFORCE
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11802488
• Report Number: 3005099803-2021-02116
• Device Sequence Number: 3962269
• Product Code: FGE
• UDI-Device Identifier: 08714729097099
• UDI-Public: 08714729097099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: 08/29/2022
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0024353100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1