MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM TUBING ACCESSORY KIT; ADJUSTABLE GASTRIC BAND TUBING

Model Number A-20401

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Taper ii.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connector type is assumed to be a taper ii.If returned, visual examination may confirm or determine another taper type associated with this event.Device labeling addresses the reported event as follows: precautions: the lap-band ap system is for single use only.Do not use a band, access port, needle or calibration tube that appears damaged (cut, torn, etc.) in any way.Do not use any of the above components 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.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

Reported as: the physician was performing a lap-band system tubing revision surgery, and upon opening the unit, noted "lap-band system tubing kit reference number (b)(4) was defective.Part number ss connector the lumen was not patent.Scrub tech was irrigating the lumen and was not able to get the tubing to work.The tubing was moved to a table and a metal chard came out while irrigating.Defective tubing (connector) caused the patient to have another surgery to correct the tubing." the patient was scheduled at a later time to have the lap-band tubing replaced.

• Brand Name: LAP-BAND SYSTEM TUBING ACCESSORY KIT
• Type of Device: ADJUSTABLE GASTRIC BAND TUBING
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5875720
• MDR Text Key: 52108285
• Report Number: 3006722112-2016-00245
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020060
• UDI-Public: 10811955020060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2016

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
• Device Operator: Physician
• Device Expiration Date: 11/11/2016
• Device Model Number: A-20401
• Device Catalogue Number: A-20401
• Device Lot Number: 2670461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• 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 Weight: 107