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

Catalog Number SAGBX

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Unspecified Infection (1930); Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported that the realize band was implanted in (b)(6) 2008.The patient initially started to lose weight and lost approximately 130 pounds.She started to gain weight back approximately two years ago.She went in for a fill and it was noted the fluid in the port was murky.It was recommended the patient wait and then come back to check and perform another fill.She continued to gain weight.She went in for a fill in (b)(6) 2014.In (b)(6) 2014, the port site started to cave in and looked different.The patient was administered antibiotics.An endoscopy procedure was performed in (b)(6) 2014 and it showed the band looked ok, but there was erosion at the port.The surgeon created a hole in the port site in order to allow the infection to drain.The band was removed on (b)(6) 2014.The patient advised that she had a lap band prior to the realize band and had the same issue with the lap band after two years.The lap band was implanted in (b)(6) 2006 and it was removed and replaced with the realize band in (b)(6) 2008.

Manufacturer Narrative

(b)(4).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).The product arrived with the band separated from the port, inclusive with catheter and locking connector.The port was received with the hooks deployed and the locking actuator fully functional.Biological debris was visible in and around the hooks.Attached is 32 cm of catheter.The straight band (black and orange in coloring) with 6 cm of catheter attached.The band was received closed, with no visible tears or cuts performed by a sharp instrument.The claim that the liquid was murky cannot be confirmed.Functional tests will not be performed as analysis of returned device would not assist to determine the root cause of the reported infection.The event description cannot to be confirmed.Evaluation of the device cannot confirm events that are physiological in nature.While it was not possible to draw a definitive conclusion regarding the root cause of the reported event, it was observed that infection is a recognized adverse event associated with gastric banding.Its causes and effects are outlined in the products instructions for use.Our investigation included, but was not limited to, a review of manufacturing and bioburden level records for the batch concerned, and no discrepancies were recorded during the manufacturing process in relation to the alleged 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: 3970347
• MDR Text Key: 4635527
• Report Number: 3005992282-2014-00045
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: SAGBX
• Other Device ID Number: BATCH #: ZJHBCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR