MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX BILIARY STENT

Model Number	ZBM08060
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a stent placement procedure, the stent was allegedly partially opened as the inner plastic of the device seemingly wasn¿t secured properly.It was further reported that the device was not used as it was technically unsterile.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: additional complaints have not been reported for this lot, previously.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.With regards to system handling precautions, the instructions for use states "visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is open or damaged".Expiration date: 09/2025.Device not returned.

• Brand Name: E-LUMINEXX BILIARY STENT
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16609193
• Report Number: 9681442-2023-00099
• Device Sequence Number: 4817459
• Product Code: FGE
• UDI-Device Identifier: 04049519009384
• UDI-Public: (01)04049519009384
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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 Model Number: ZBM08060
• Device Catalogue Number: ZBM08060
• Device Lot Number: ANGW0375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown