MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Surgical procedure, additional (2564)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported that the realize band was removed from the patient on (b)(6) 2014 due to complications from the gastric band procedure.The complications were unknown at the time of the call.There was no additional information at the time of the call.One device will be returned.

Manufacturer Narrative

(b)(4): information anticipated, but unavailable at this time.No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Additional information: upon visual inspection, it was noted that the balloon was discolored in the center of the band fold.The discoloration was of a dark brown color.The port was encrusted on front and back with biological tissue.Leak test performed - device failed.A small leak exists at the second point of reference, the balloon closed end, extender side.The leak appears to be along where the glue attaches the balloon to the silicone band.Biological debris prohibiting locking and unlocking of the device.The port was disconnected from the catheter / locking connector and immersed in koh solution for 24 hours.Post treatment of koh solution, the port deploys from locked to unlocked position without any resistance.The port is fully functional.Some damage is evident on the face of the port.This may be due to a device used to grab the port or possibly derived from the use with the port applier.The complaint cannot be confirmed as no specifics of the complaint have been communicated other than the band was removed 'due to complications from the gastric band procedure'.No information regarding implant date has been conferred therefore we cannot know if this leakage is due to wear and tear.It is not possible to draw conclusion as to the root cause.There are many possibilities for root cause, for example device wear and tear, potential band defect or user mishandling.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process.Manufacturing practices were reviewed also with respect to testing of the swedish adjustable gastric band (sagb) prior release.It was noted that 100% of all devices are leak tested.This is therefore unlikely to be a manufacturing issue.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4180474
• MDR Text Key: 5020535
• Report Number: 3005992282-2014-00059
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1