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

Model Number	M00534680
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was opened to be used for an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed on (b)(6) 2022.During the preparation, it was noted that the package was damaged and the seal was destroyed.The stent is no longer sterile and could not be used anymore.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was opened to be used for an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed on (b)(6) 2022.During the preparation, it was noted that the package was damaged and the seal was destroyed.The stent is no longer sterile and could not be used anymore.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a1801 captures the reportable event of contamination.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the pouch was already opened when received, it was inspected and it presents wrinkles in some areas, once the package is opened the sterility of the device could have been compromised.Visual analysis identified that the heat seal runs throughout entire length of the pouch without any breakage.The upper section of the pouch has evidence that the package was previously sealed.No other problem with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; visual assessment identified the that the pouch was already opened when received, it was inspected and it presents wrinkles in some areas.As per complaint information the issue was identified during preparation.It is most likely that handling and manipulation of the device during transport/storage could have contributed with the event, from the evidence observed on the device, it can be determined that the heat seal runs throughout entire length of the pouch without any breakage and the upper section of the pouch had evidence that the package was previously sealed.Therefore, based on the information available and the analysis performed, the investigation conclusion code for the reported event will be documented as "cause traced to transport/storage" due to problems traced to the inappropriate transport or storage of the device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15090661
• Report Number: 3005099803-2022-03856
• Device Sequence Number: 14441468
• Product Code: FGE
• UDI-Device Identifier: 08714729787235
• UDI-Public: 08714729787235
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 03/21/2024
• Device Model Number: M00534680
• Device Catalogue Number: 3468
• Device Lot Number: 0029085102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/24/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown