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

Model Number	M00537180
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
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.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 on (b)(6) 2018 as no event date was reported.Block f10; h6: device code of 1444 captures the reported event of seal compromised.Block h10: product analysis: a visual evaluation of the returned advanix pancreatic was performed.The device returned in its original pouch completely sealed, the pouch did not present holes or cuts that could compromise sterility; however, brown dust was found in the corners of the pouch (on the outer side of the seal); consequently, not confirming the reported complaint.Based on the product analysis, it was confirmed that the pouch and components are free of foreign material.During the manufacturing inspection, it was detected the damage found in the pouch.However, it is most likely that handling and manipulation of the device during shipping/storage could have contributed with the encountered brown dust issue, since, this condition indicates that likely the device was incorrectly transported or storage in the field, therefore, the most probable conclusion code for the encountered issue will be documented as cause traced to transport/storage since problems traced to the inappropriate transport or storage of the device.Therefore the most probable root cause for this event is no problem detected', since the device complaint or problem cannot be confirmed.Dhr review was performed and 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.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: 8800057
• Report Number: 3005099803-2019-03659
• Device Sequence Number: 14230395
• 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): 09/10/2019

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: 08/14/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1