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	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 hepatic portal during a biliary stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon had a pinhole-like hole.The procedure was completed with another maxforce biliary dilatation balloon.There have been no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: investigation results a visual examination of the returned complaint device found that the balloon did not have any visual defects and lookled normal.The inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge but none of them showed abnormalities.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the body 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, the amount of strength applied by the customer during the movement of the balloon and/or 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.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the hepatic portal during a biliary stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon had a pinhole-like hole.The procedure was completed with another maxforce biliary dilatation balloon.There have been no patient complications reported as a result of this 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: 9515931
• Report Number: 3005099803-2019-06185
• Device Sequence Number: 11233632
• Product Code: FGE
• UDI-Device Identifier: 08714729097068
• UDI-Public: 08714729097068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/11/2020

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: 05/20/2022
• Device Model Number: M00567370
• Device Catalogue Number: 6737
• Device Lot Number: 0023826070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1