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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2020
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).Investigation results: a visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and were in good condition.Microscopic analysis was performed, and it was noticed that the balloon had a pinhole.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to the pinhole located over the ro marker in the proximal section.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the interaction between the scope and the balloon.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 instructions for use (ifu)/product label.
Event or Problem Description
Boston scientific corporation received an unauthorized return of a maxforce biliary dilatation balloon.It was found that the balloon had a 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: 10791367
• Report Number: 3005099803-2020-05026
• Device Sequence Number: 16426078
• Product Code: FGE
• UDI-Device Identifier: 08714729097051
• UDI-Public: 08714729097051
• Combination Product (Y/N): N
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 06/27/2022
• Device Model Number: M00567340
• Device Catalogue Number: 6734
• Device Lot Number: 0024028837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1