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

Model Number	M00567340
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the returned complaint device found the balloon did not have any visual defects and was in a good condition.The catheter of the device was carefully inspected and no damages were found.Microscopic analysis was performed and it was noticed that the balloon have pinholes.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to pinholes located over the proximal and distal ro markers of the balloon material, thereby the reported event of balloon leak was confirmed.This failure is likely due to factors encountered during the procedure, such as handling of the device, and/or the interaction between the balloon and the scope 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
Note: this report pertains to one of two maxforce biliary dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two maxforce biliary dilatation balloons were used during a bile duct dilation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon would not inflate due to a leak.The same issue occurred with the second maxforce balloon.The procedure was completed with another maxforce biliary dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon have pinholes; therefore, this is now an mdr reportable event.

• 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: 10595312
• Report Number: 3005099803-2020-04236
• Device Sequence Number: 11050804
• Product Code: FGE
• UDI-Device Identifier: 08714729097051
• UDI-Public: 08714729097051
• 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
• Report Date (Section B): 09/28/2020

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: 08/18/2022
• Device Model Number: M00567340
• Device Catalogue Number: 6734
• Device Lot Number: 0024288342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1