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

Model Number	ZBM12040
Medical Device Problem Codes	Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample the reported event could not be confirmed.No indication could be found that a successful tracking was impossible.The alleged piece of glue or melted plastic that prevented the system from successful tracking could not be found.Furthermore, during evaluation a system compatible 0.035" guidewire could be successfully inserted and the stent could be released at a low force level.Therefore, the investigation will be closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instruction for use (ifu) sufficiently addresses the potential risks.Regarding the usage of a damaged product the ifu states: 'visually inspect the bard luminexx biliary stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.' and 'should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.' 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 bard.
Event or Problem Description
It was reported that during deployment procedure a biliary stent allegedly could not be advanced because a piece of melted glue or plastic was allegedly found attached to the outer surface.Reportedly, the device was removed without any issues and another stent system was used to complete the procedure.There was no reported patient injury.

• Brand Name: E-LUMINEXX BILIARY STENT
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7072854
• Report Number: 9681442-2017-00302
• Device Sequence Number: 685107
• Product Code: FGE
• UDI-Device Identifier: 04049519010366
• UDI-Public: (01)04049519010366
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 07/29/2019
• Device Model Number: ZBM12040
• Device Catalogue Number: ZBM12040
• Device Lot Number: ANAU3829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR