MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. RAPIDPORT EZ ACCESS PORT KIT; ADJUSTABLE GASTRIC BAND

Model Number	B-2304
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Strain relief medwatch sent to the fda on 06/28/2016.This report captures the patient's replacement port/tubing that was removed due to leakage.Device evaluation summary: the device was returned for analysis, and visual examination confirmed the connector type as a strain relief.A leak test was performed on the port, and no leakage was noted.A fill inspection test was performed on the port tubing, and no blockage or resistance to flow was noted.Under microscopic analysis the port tubing was observed to have wear/abrasions.Device labeling addresses the reported event of possible port/band/tubing leak as follows: precautions: care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.Failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.Adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warnings: patients should be advised that the lap-band system is a long term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.
Event or Problem Description
Reported as: a patient with the lap-band system was reported to have "started losing restriction, and radiographs once again demonstrated a broken connective tubing which was well away from the abdominal wall and well away from the stress point." the patient had their replacement port and their lap-band system removed and replaced.

• Brand Name: RAPIDPORT EZ ACCESS PORT KIT
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 5755155
• Report Number: 3006722112-2016-00164
• Device Sequence Number: 465528
• Product Code: LTI
• UDI-Device Identifier: 10811955020244
• UDI-Public: 10811955020244
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/15/2016
• Device Model Number: B-2304
• Device Catalogue Number: B-2304
• Device Lot Number: 2590131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2016
• Initial Report FDA Received Date: 06/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 76