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

Model Number	M00537510
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ pancreatic stent was to be used for an unknown procedure on an unknown date.According to the complainant, during unpacking, it was observed that the packaging of the stent was already damaged and the sterile seal was compromised.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual evaluation of the returned device found there was cut on the tyvek side of the package.The cut appears to has been made with a sharp tool.Based on the product analysis, the failure was noted during unpacking and outside the patient, it is possible that the way in which the device was handled and manipulated during its process of unpacking may have contributed to the condition of the unit returned (package cut).The damage found was caused with an unknown/sharp instrument since the section of the package found cut has its appearance without irregularities and the cut looks very clean.During its manufacturing process the product is inspected in regards to its integrity, however there is no control on how the units are handled at the field, it was concluded the way in which the unit was handled and manipulated during preparation may have contributed to the failure.Therefore, ¿handling damage¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ pancreatic stent was to be used for an unknown procedure on an unknown date.According to the complainant, during unpacking, it was observed that the packaging of the stent was already damaged and the sterile seal was compromised.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX¿ PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela IN ; CS
• MDR Report Key: 7323475
• Report Number: 3005099803-2018-00702
• Device Sequence Number: 120363
• Product Code: FGE
• UDI-Device Identifier: 08714729856283
• UDI-Public: 08714729856283
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

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: 05/31/2019
• Device Model Number: M00537510
• Device Catalogue Number: 3751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1