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

Model Number	M00567380
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the bile duct during a dilation procedure performed on an unknown date.According to the complainant, during the procedure, the balloon become broken and would not inflate again.The procedure was completed with another maxforce biliary dilatation balloon.No patient complications have been reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block h6: device code 1074 captures the reportable issue of balloon burst.Block h10: investigation results: a visual examination of the returned complaint device found that the balloon did not show any visual defects and looked normal.The catheter of the device was carefully inspected and no damages were found.Microscopic examination was performed, and it was found that the balloon had a pinhole.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole located at the distal section of the balloon material.This failure is likely due to factors encountered during the procedure, such as handling of the device, and/or the interaction between the scope and the balloon during the procedure could have possibly affected the device performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.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 directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the bile duct during a dilation procedure performed on an unknown date.According to the complainant, during the procedure, the balloon become broken and would not inflate again.The procedure was completed with another maxforce biliary dilatation balloon.No patient complications have been reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10398776
• Report Number: 3005099803-2020-03184
• Device Sequence Number: 2743373
• Product Code: FGE
• UDI-Device Identifier: 08714729097075
• UDI-Public: 08714729097075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 06/16/2022
• Device Model Number: M00567380
• Device Catalogue Number: 6738
• Device Lot Number: 0023961533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1