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

Model Number	M00567420
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual examination of the returned complaint device found the balloon did not show visual defects and looked 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 on the body of the balloon, over the ro marker.It is possible that the failure could be caused by some factors encountered during the procedure, and/or related to the handling/manipulation.However, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.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 bile duct during a dilation procedure performed on (b)(6) 2019.It was found that the balloon had a pinhole.Reportedly, 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 investigation result of balloon pinhole.Block h10: investigation results visual examination of the returned complaint device found the balloon did not show visual defects and looked 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 on the body of the balloon, over the ro marker.It is possible that the failure could be caused by some factors encountered during the procedure, and/or related to the handling/manipulation.However, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: the report submitted on this event on 28may2019 (report number) was submitted in error, as the event was a duplicate of report number 3005099803-2019-01826.Therefore, the information for this event can be found under report number 3005099803-2019-01826.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the bile duct during a dilation procedure performed on (b)(6) 2019.It was found that the balloon had a pinhole.Reportedly, 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: 8646614
• Report Number: 3005099803-2019-02672
• Device Sequence Number: 2091741
• Product Code: FGE
• UDI-Device Identifier: 08714729097099
• UDI-Public: 08714729097099
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 08/02/2019

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 Expiration Date: 08/19/2021
• Device Model Number: M00567420
• Device Catalogue Number: 6742
• Device Lot Number: 0022536160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1