MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY MAXFORCE¿; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00567410
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 dilation balloon was used during a procedure performed in the common bile duct on an unknown date.According to the complainant, during the procedure, the balloon appeared to be ruptured when inflated.The procedure was completed with another maxforce dilation balloon.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce biliary dilation balloon was used during a procedure performed in the common bile duct on an unknown date.According to the complainant, during the procedure, the balloon appeared to be ruptured when inflated.The procedure was completed with another maxforce dilation balloon.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A visual examination of the complaint device revealed that the device did not have any visual defects.The inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge and there were no abnormalities found.Functional analysis was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to two pinholes found on the body of the balloon.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

• Brand Name: MAXFORCE¿
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7756802
• Report Number: 3005099803-2018-02471
• Device Sequence Number: 13879405
• Product Code: FGE
• UDI-Device Identifier: 08714729097082
• UDI-Public: 08714729097082
• Combination Product (Y/N): N
• 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): 07/18/2018

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: 10/08/2020
• Device Model Number: M00567410
• Device Catalogue Number: 6741
• Device Lot Number: 0021230855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1