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

Catalog Number RLZB32

Device Problem Fluid/Blood Leak (1250)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that following a gastric band procedure, everything was great until last year.Patient kept getting fills, but it seemed like the fluid was leaking out.A leak was suspected as less than 4cc was withdrawn when 9.5cc should have been in the band.The patient has since had multiple injections and withdraws of fluid confirming that there is a leak present.It is unknown if the leak is in the tubing or the band balloon.A barium swallow was performed to confirm that there was no band slippage and it has not slipped.The surgeon has offered to convert the band to a sleeve, but the patient had success with the band and was happy with the weight loss achieved prior to the leak, therefore, would like to have the band replaced if possible.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.Band was implanted the (b)(6) 2010.

• 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: 4703243
• MDR Text Key: 17214323
• Report Number: 3005992282-2015-00016
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Other Device ID Number: 20705036004001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1