MAUDE Adverse Event Report: ALLERGAN LAP-BAND ACCESS PORT KIT (UNK SIZE)

Catalog Number LAP-BAND ACCESS PORT KIT (UNK

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Healthcare professional reported device had a leaking access port.Port has been removed.

Manufacturer Narrative

Taper unknown.Medwatch sent to fda on: 12/31/2014.The reporter of the complaint was asked to return the product for analysis as well as to indicate the product serial number, date of event, implant date and explant date.The information has not yet been received by allergan.The connector type cannot be identified nor an assumption be made as to the type of connector associated with this complaint because no serial number or implant date was given.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Further information from the reporter regarding the serial number, implant date, date of occurrence, explant date, and patient have been requested.Device labeling addresses the possible outcome of leakage as follows: "deflation of the band may occur due to leakage from the band, the port or the connector tubing.".

Manufacturer Narrative

Taper ii.Visual examination of the returned device determined the access port tubing connector to be a taper ii.Analysis noted a striated opening in the access port tubing at the stainless steel connector consistent with surgical removal of the device.Analysis noted a thinner surface at the port tubing consistent with wear and tear.

• Brand Name: LAP-BAND ACCESS PORT KIT (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de herdia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w. howard lane suite 100; austin, TX 78753-5506 ; 5128132638
• MDR Report Key: 4381465
• MDR Text Key: 5288154
• Report Number: 2024601-2014-00692
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

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 Catalogue Number: LAP-BAND ACCESS PORT KIT (UNK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2015
• 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