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

Model Number	M00567420
Medical Device Problem Code	Burst Container or Vessel (1074)
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).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 channel during a dilatation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician inserted the balloon through the duodenoscope and the balloon was attempted to be inflated to 8-10 atm; however, the balloon burst.The procedure was completed with another 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 stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: investigation results visual examination of the returned complaint device found the balloon did not show visual defects; the balloon was not burst 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.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 device, 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.Block h11: report number 3005099803-2019-02672 submitted on 28may2019 was confirmed to be a duplicate of this report, report number.Therefore, all information pertaining to this event, including the product analysis, will now be under report number.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the bile channel during a dilatation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician inserted the balloon through the duodenoscope and the balloon was attempted to be inflated to 8-10 atm; however, the balloon burst.The procedure was completed with another 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 stable.

• 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: 8527798
• Report Number: 3005099803-2019-01826
• Device Sequence Number: 11358948
• 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: 03/22/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 04/18/2019
• 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