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

Model Number	M00537290
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 during unpacking, the barb sleeve cover of the advanix pancreatic stent was loose from the sealed plastic thermoformed blister tray and was found in the plastic pouch.The sterility of the device was confirmed to be compromised so the physician discontinued use of this device.Another advanix pancreatic stent was opened and used to complete the procedure.There were no patient issues.A photo of the complaint device was provided showing the barb sleeve cover out of its original position within the device packaging.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6).Block h6: device code 1444 captures the reportable event of unsealed device packaging.Block h10: the complaint device was not returned for analysis, however the customer provided a couple of photos of the device.The pictures show a sealed package, no visual damages/defects were identified on the device/package.No other issues with the device were noted.The reported event was not confirmed.Based on the provided and collected information, device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; after analysis it was determined no visual issues/defects were identified with the device and package.It was stated that the orange part was found in the plastic pouch, however according to procedure pack pancreatic pigtail stents, it is the correct way to package the component.Therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that during unpacking, the barb sleeve cover of the advanix pancreatic stent was loose from the sealed plastic thermoformed blister tray and was found in the plastic pouch.The sterility of the device was confirmed to be compromised so the physician discontinued use of this device.Another advanix pancreatic stent was opened and used to complete the procedure.There were no patient issues.A photo of the complaint device was provided showing the barb sleeve cover out of its original position within the device packaging.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6) block h6: device code 1444 captures the reportable event of unsealed device packaging.Block h10: the returned unopened advanix pancreatic stent was analyzed, and a visual evaluation noted that the barb sleeve cover was observed inside the sterilized package.The pictures provided revealed that the photos provided by the user showed the barb sleeve inside the sealed and sterilized package.No other issues with the device were noted.The reported event was not confirmed.The complaint device was returned for analysis and the customer provided a couple of photos of the device.The returned unopened advanix pancreatic stent was returned for analysis.The barb sleeve cover was observed inside the sterilized package.Also media inspection revealed that the photos provided by the user showed the barb sleeve inside the sealed and sterilized package.Therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: correction to block e1: initial reporter first name; initial reporter last name block e3: occupation.
Event or Problem Description
It was reported to boston scientific corporation that during unpacking, the barb sleeve cover of the advanix pancreatic stent was loose from the sealed plastic thermoformed blister tray and was found in the plastic pouch.The sterility of the device was confirmed to be compromised so the physician discontinued use of this device.Another advanix pancreatic stent was opened and used to complete the procedure.There were no patient issues.A photo of the complaint device was provided showing the barb sleeve cover out of its original position within the device packaging.

• 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: 10862592
• Report Number: 3005099803-2020-05539
• Device Sequence Number: 14394315
• Product Code: FGE
• UDI-Device Identifier: 08714729856887
• UDI-Public: 08714729856887
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2021

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: 05/30/2021
• Device Model Number: M00537290
• Device Catalogue Number: 3729
• Device Lot Number: 0024857266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/19/2020; 09/09/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/15/2020; 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1