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

Model Number	M00567380
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon popped.No patient complications have been reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.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 dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon popped.No patient complications have been reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 04jan2019.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1074 captures the reportable issue of balloon burst.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon popped.No patient complications have been reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 04jan2019.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: problem code 1074 captures the reportable issue of balloon burst.H10: investigation results: a visual examination of the returned complaint device confirmed that the balloon was burst/ruptured; the damage was located at the proximal section of the balloon.The inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge but none of them showed abnormalities.No other issues noted on the device.Functional evaluation could not be performed due to the condition of the returned device.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.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.

• 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: 8213777
• Report Number: 3005099803-2018-62327
• Device Sequence Number: 19377961
• Product Code: FGE
• UDI-Device Identifier: 08714729097075
• UDI-Public: 08714729097075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

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: 04/22/2019
• Device Model Number: M00567380
• Device Catalogue Number: 6738
• Device Lot Number: 0019176150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/04/2019; 01/30/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/23/2019; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR