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

Model Number	M00534680
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of this event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of this event.(b)(6).(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 when the device was received, it was noticed that the packaging of an advanix biliary stent was broken and the sterility of the device was compromised.The exact date of this event was not reported.There was no patient or procedure involved.
Additional Manufacturer Narrative
A visual evaluation of the device found that a clear plastic side of the pouch where the label goes placed was found to be broken, also the label was broken and the product has wrinkles indicating the manipulation of the unit.Based on the product analysis, it is possible that the way in which the device was handled and manipulated during the processes of shipping/receiving and/or storage may have contributed to the failure encountered (pouch and label broken); the defect found is typically caused due to incorrect manipulation of the product while its transport, taking into consideration that the unit was returned inside its original package.Additionally, the returned product has wrinkles indicating the manipulation of the unit.Therefore,cause traced to transport/storage is selected as the most probable root cause for the complaint.A dhr review was performed and no anomalies were observed.
Event or Problem Description
It was reported to boston scientific corporation that when the device was received, it was noticed that the packaging of an advanix biliary stent was broken and the sterility of the device was compromised.The exact date of this event was not reported.There was no patient or procedure involved.

• 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: 8011169
• Report Number: 3005099803-2018-61068
• Device Sequence Number: 1379863
• Product Code: FGE
• UDI-Device Identifier: 08714729787235
• UDI-Public: 08714729787235
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 12/18/2019
• Device Model Number: M00534680
• Device Catalogue Number: 49845
• Device Lot Number: 0021524744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1