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

Model Number ZBM08060

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 311971994
• Report Number: 9681442-2023-00099
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 04049519009384
• UDI-Public: (01)04049519009384
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1