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

Model Number	M00537180
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(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 two advanix pancreatic stents were received by an account with a hole in the device packaging.This caused the sterility of the device to become compromised.No further issues were reported.There was no patient or procedure involved at the time this incident was noticed, and the device was never opened or used by the account.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 06/01/2018 as no event date was reported.Block f10; h6: device code of 1444 captures the reported event of seal compromised.Block h10: a visual evaluation of the returned advanix pancreatic was performed.The device returned in its original pouch, the pouch has drag marks and it present an open hole in the tyvek section compromising the seal, additionally, it's important to mention that dirt was found inside of the pouch due to the observed open hole in the tyvek area.The marks indicates that likely the pouch was dragged during manipulation or storage.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, since, the marks indicates that likely the pouch was dragged during manipulation or storage, additionally, boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices and handled/manipulated or storage in the field.Therefore the most probable root cause for this event is 'cause traced to transport/storage' based on the facts that dhr did not show any abnormalities and that process controls are in place to prevent this failure from happening, 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 two advanix pancreatic stents were received by an account with a hole in the device packaging.This caused the sterility of the device to become compromised.No further issues were reported.There was no patient or procedure involved at the time this incident was noticed, and the device was never opened or used by the account.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8800059
• Report Number: 3005099803-2019-03658
• Device Sequence Number: 11482309
• Product Code: FGE
• UDI-Device Identifier: 08714729856658
• UDI-Public: 08714729856658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 10/20/2019
• Device Model Number: M00537180
• Device Catalogue Number: 3718
• Device Lot Number: 0022026852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1