MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR AND BILIARY STENT SYSTEM

Catalog Number	EX070401CS
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any patient details.There was no patient involvement.
Event or Problem Description
It was reported that prior to a stenting procedure, a hole was detected in the sterile packaging.There was no patient involvement; the device was not used.
Additional Manufacturer Narrative
The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.The evaluation of the returned device confirmed that the sterile pouch showed a pinhole in the white polymer material leading to a loss of the sterile barrier.The outer box was found to be in good condition and the delivery system inside the pouch was found to be free of damages or sharp edges which lead to the conclusion that the pinhole was caused by external effects on the outer surface of the pouch.Potential contributing factors to the reported event been evaluated.Previous investigations of similar events have been reviewed.This kind of damage may be related to the unpacking of the device since the pinhole was identified after unpacking.It also may be related to the handling of the product after removal from the card box.The production working steps after the sealing process have been evaluated and it was found that there were no tools or accessories in use that could have caused a pinhole of this dimension.On the basis of the information available, a definite root cause for the reported event could not be identified.The ifu states: "carefully inspect the pouch for damage to the sterile barrier." and "do not use if pouch is opened or damaged.".

• Brand Name: LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5723242
• Report Number: 9681442-2016-00164
• Device Sequence Number: 18133
• Product Code: NIP
• UDI-Device Identifier: 04049519001081
• UDI-Public: (01)04049519001081(17)180324(10)ANAQ3354
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2016

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: 03/24/2018
• Device Catalogue Number: EX070401CS
• Device Lot Number: ANAQ3354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2016
• Supplement Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1