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

Model Number	M00534690
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 during unpacking, it was noticed that the advanix biliary stent packaging label was torn and the sterility of the device was compromised.There was no issue noted with the outer federal express box that the device was shipped in.There was no patient or procedure involved at the time this incident was noticed.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 05/01/2019 as no event date was reported.Block f10: problem code 1444 captures the reported event of seal compromised.Block h10: investigation analysis a visual evaluation of the returned advanix billiary, the device was returned in its original pouch, the pouch was torn and it has hole at the front side (label area), compromising the seal; consequently, confirming the reported complaint.Based on the product analysis, it is most likely that handling and manipulation of the device during shipping/storage could have contributed with the reported issue, additionally boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control on how the devices and handled/manipulated or storage in the field.Based on the facts that dhr did not show any abnormalities and that process controls are in place to prevent this failure from happening, the most probable conclusion code will be documented as 'cause traced to transport/storage' since problems traced to the inappropriate transport or storage of the device.A review of the device history record (dhr) was performed, no anomalies were observed.The review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported to boston scientific corporation that during unpacking, it was noticed that the advanix biliary stent packaging label was torn and the sterility of the device was compromised.There was no issue noted with the outer federal express box that the device was shipped in.There was no patient or procedure involved at the time this incident was noticed.

• 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: 8700765
• Report Number: 3005099803-2019-03030
• Device Sequence Number: 1644178
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• 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
• Report Date (Section B): 07/22/2019

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: 04/14/2021
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0023644700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1