MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ADVANIX¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.However, the complainant reported that the device was not expired.(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 previously implanted advanix¿ biliary stent was removed from a patient during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2017.According to the complainant, during the stent removal procedure while the physician was removing the stent, the stent broke into two pieces.The broken piece went up into the common bile duct was removed with a balloon extractor and the procedure was completed.The entire device was removed with no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "fine".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the stent has some blackened areas, also it was necked and kinked in the proximal section, the proximal section of the stent was broken, including the barb.Based on the product analysis, most likely some anatomical/procedural factors were encountered during the procedure which may have limited the overall performance of the device.The damages found on the stent are typically made due to grab and pull the stent with the snare during the stent removal, excessive force, procedural and anatomical factors can result in stent breakage during stent removal.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.Labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted advanix biliary stent was removed from a patient during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2017.According to the complainant, during the stent removal procedure while the physician was removing the stent, the stent broke into two pieces.The broken piece went up into the common bile duct was removed with a balloon extractor and the procedure was completed.The entire device was removed with no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "fine".

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6888570
• Report Number: 3005099803-2017-02879
• Device Sequence Number: 705908
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention