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	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Investigation results: a visual examination of the returned complaint device revealed that the balloon and the catheter did not have any visual defects and was in a good condition.A several quantity of dry contrast was also noticed inside the balloon.Functional analysis could not be performed as the balloon lumen was blocked, and it was not possible to unclog it.The balloon was visually inspected through high magnification, and it was discovered that the balloon had a pinhole located over the proximal ro marker of the balloon material.This failure is likely due to factors or conditions related to procedure and/or the interaction with the scope that could have affected its 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.The anatomy location of the procedure was the bile duct.It was reported to boston scientific corporation that two maxforce biliary dilatation balloons were used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the balloon was successfully inflated to about 6 to 8 atm; however, the balloon loss pressure and eventually would not inflate anymore.Reportedly, the balloon was removed from the patient and another maxforce balloon was used.The second balloon was inflated to 2 atm for testing prior to procedure and there were no issues noted; however, the balloon would not inflate when inside the patient.The second balloon was then removed from the patient, and liquid was noted coming out of the balloon.The procedure was completed with a third maxforce biliary dilatation balloon.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: 9991085
• Report Number: 3005099803-2020-01754
• Device Sequence Number: 3836069
• 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): 04/23/2020

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: 06/04/2022
• Device Model Number: M00567340
• Device Catalogue Number: 6734
• Device Lot Number: 0023903427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1