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

Model Number	M00534320
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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 an advanix biliary stent was received on (b)(6) 2021.It was reported that the stent arrived in the facility with a hole in the package and the sterile barrier was compromised.There were no patient involvement and this device was not used in a procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was received on (b)(6) 2021.It was reported that the stent arrived in the facility with a hole in the package and the sterile barrier was compromised.There were no patient involvement and this device was not used in a procedure.
Additional Manufacturer Narrative
Block h6: medical device code a020503 captures the reportable event of device contaminated.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the device returned in its sealed pouch.The heat seal runs throughout entire length of the pouch without any breakage.The pouch and label are torn.No other problems 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 pouch and label torn.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 an something was rubbed against the product which resulted in tearing the package and label.Review and analysis of all available information indicated that the root cause of the problems found is 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
• MDR Report Key: 11672005
• Report Number: 3005099803-2021-01645
• Device Sequence Number: 2982340
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 03/01/2023
• Device Model Number: M00534320
• Device Catalogue Number: 3432
• Device Lot Number: 0026891641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1