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

Model Number	M00567340
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as no event date was reported.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during preparation, the balloon was inflated outside the patient for testing; however, the balloon would not inflate due to a pinhole.The procedure was completed with another maxforce biliary dilatation balloon.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during preparation, the balloon was inflated outside the patient for testing; however, the balloon would not inflate due to a pinhole.The procedure was completed with another maxforce biliary dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 11/01/2020 as no event date was reported.Block h6: device code a041001 captures the reportable event of balloon pinhole.Block h10: investigation result a visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and were in a good condition.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to the balloon being ruptured.Microscopic inspection confirmed that the balloon was burst.The balloon bursting does not confirm the reported event of the balloon pinhole.This failure is likely due to factors encountered during the procedure, such as the interaction between the device with the scope, the technique used by the physician, and/or the movement of the balloon during the procedure, causing to the found failure of balloon burst.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.

• 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: 11021719
• Report Number: 3005099803-2020-05990
• Device Sequence Number: 19957226
• Product Code: FGE
• UDI-Device Identifier: 08714729097051
• UDI-Public: 08714729097051
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 04/13/2021

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: 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: 03/12/2021
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1