MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INTERNATIONAL, LAP BAND, RAPID-PORT EZ, PORT APPLIER; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-20300

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 04/22/2015

Event Type  malfunction  

Manufacturer Narrative

Rapidport ez strain relief.The product associated with this report will not be returned for analysis.Based upon the implant date provided by the reporter the connector type is either a strain relief.Visual examination may determine the connector type associated with this report.Device labeling addresses the possible outcome of a damaged device: ¿the lap-band ap system is for single use only.Do not use a band, access port, needle or calibration tube which appears damaged (cut, torn, etc.) in any way.Do not use one of them if the package has been opened or damaged, or if there is any evidence of tampering.If packaging has been damaged, the product may not be sterile and may cause an infection.¿ "caution: the band, access port and calibration tube may be damaged by sharp objects and manipulation with instruments.A damaged device must not be implanted.For this reason, a stand-by device should be available at the time of surgery.".

Event Description

Healthcare professional reported the rapidport ez port applier broke during the adjustment of the lap band.The port applier was retrieved and the abdominal wall was checked for the presence of foreign bodies.

• Brand Name: INTERNATIONAL, LAP BAND, RAPID-PORT EZ, PORT APPLIER
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; bulding 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5095360
• MDR Text Key: 26476601
• Report Number: 3006722112-2015-00378
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician Assistant
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-20300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• 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
• Patient Outcome(s): Other