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

Model Number	M00567370
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).Investigation result: visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.A functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole close to the proximal section of the balloon.Microscopic inspection was done and confirmed the balloon had a pinhole.With all the available information, bsc concludes that it is most likely that procedural or anatomical factors encountered during the procedure, such as the manner in which the technique used by the physician, and/or the interaction between the scope and the balloon during the procedure, could have contributed to the reported failure of balloon pinhole.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 instructions for use (ifu)/product label.
Event or Problem Description
Boston scientific corporation received a maxforce biliary dilation balloon device with no associated information.This event has been deemed reportable based on the investigation results of balloon pinhole.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: 12099645
• Report Number: 3005099803-2021-03133
• Device Sequence Number: 11812053
• Product Code: FGE
• UDI-Device Identifier: 08714729097068
• UDI-Public: 08714729097068
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 10/14/2022
• Device Model Number: M00567370
• Device Catalogue Number: 6737
• Device Lot Number: 0024596558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/01/2021
• Patient Sequence Number: 1