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

Model Number ZBM14060

Device Problem Premature Activation (1484)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that prior to the stent placement procedure, part of the tri-axial release system allegedly appeared to retract.The procedure was completed using another device.There was no reported patient contact.

Manufacturer Narrative

H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the physical sample was not returned for evaluation.Also photos were not provided for evaluation which leads to inconclusive results.The customer reported that the system appeared retracted during flushing and that there was no visible damage to the device prior to this realization, the inner pouch of the device packaging didn't appear compromised.Based on available information investigation was closed with inconclusive result for premature activation.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding potential damages the instructions for use states: "visually inspect the bard e luminexx biliary stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".H10: d4 (expiry date: 10/2025), g3.H11: h6 (result, conclusion).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported that prior to stent placement procedure, the part of the tri-axial release system was allegedly appeared to retract.The procedure was completed using another device.There was no reported patient contact.

Event Description

It was reported that prior to stent placement procedure, the part of the tri-axial release system was allegedly appeared to retract.The procedure was completed using another device.There was no reported patient contact.

Manufacturer Narrative

H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was returned for evaluation.The stent was still loaded in the delivery catheter and in place.The system was found disassembled, and the grip was missing.The integrity of the sample was compromised such that further investigations are not possible; reproduction of the reported event is not possible which makes it inconclusive.It was reported that the system appeared retracted during flushing and that there was no visible damage to the device prior to this realization.Therefore, based on available information and the evaluation of the returned sample, the investigation is closed with inconclusive result for premature activation.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risks.Regarding potential damages the instructions for use states: "visually inspect the bard e luminexx biliary stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".H10: d4 (expiration date: (b)(6) 2025), g3, h2 h11: h6 (method) h11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

• 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: 17223663
• MDR Text Key: 318084756
• Report Number: 9681442-2023-00248
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 04049519010441
• UDI-Public: (01)04049519010441
• 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,Followup,Followup
• Report Date: 07/21/2023

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
• Device Operator: Health Professional
• Device Model Number: ZBM14060
• Device Catalogue Number: ZBM14060
• Device Lot Number: ANGX1537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/05/2023; 07/24/2023
• Supplement Dates FDA Received: 07/07/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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