MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Fluid/Blood Leak (1250)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported post implanted on a gastric band, the patient was not losing weight and some testing was done.It was discovered that there was a leak in the band noticed under fluoroscopy.The surgeon is going to remove the band and re-implant another band.It is unknown the date of the removal of the band.

Manufacturer Narrative

(b)(4): information unavailable.Device remains implanted.

Manufacturer Narrative

(b)(4).Additional information: the device was returned with one visible tear on the balloon, which was confirmed during leak testing.This tear was localized on the second fold line.Balloon leakage is a recognized adverse event associated with gastric banding.Its causes and consequences are outlined within the product's instructions for use (ifu) and include improper handling during surgery, physiological reaction to the material as well as general deterioration over time.Manufacturing records were reviewed, it is noted that all devices are leak tested and visually inspected prior to release, it is therefore unlikely that a manufacturing issue contributed to the reported event.The manufacturing records were reviewed and no discrepancies were found during the manufacturing process.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• 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: 3870935
• MDR Text Key: 4569214
• Report Number: 3005992282-2014-00030
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2014

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: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: RLZB22
• Other Device ID Number: ZJKBNB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2008
• 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