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	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 was in a good condition.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located at the proximal section of the balloon.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 technique used by the physician during the procedure and/or the interaction between the scope and the balloon.Therefore, the most probable root cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
Note: this report pertains to one of two maxforce biliary dilation balloons used during the same procedure.It was reported to boston scientific corporation that two maxforce biliary dilation balloons were used in the bile duct during a bile duct dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon would not inflate.The same issue "ocurred" in the second maxforce biliary dilation balloon.The procedure was completed with a different device.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 fine.Investigation results revealed that the balloon had a pinhole; 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: 9516362
• Report Number: 3005099803-2019-06190
• Device Sequence Number: 16994951
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2019

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 Model Number: M00567370
• Device Catalogue Number: 6737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1