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

Catalog Number RLZB22

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Surgical procedure (2357)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Patient presents at annual visit with complaints of vomiting all solid food for the last 4 to 6 weeks starting around (b)(6) 2014.Her band was previously deflated for voice hoarseness and is currently empty.Her routine ugi performed the (b)(6) 2014 was reviewed and findings appear normal.The only action to take for this is band removal which is scheduled for (b)(6)2014.Vomiting is likely psychogenic in nature based on normal ugi findings.

Manufacturer Narrative

(b)(4).Should information be provided later, a supplemental medwatch will be sent.The band was returned with approximately 15cm of catheter attached.The buckle on the band was slit, this likely occurred due to the aid of a sharp instrument upon band removal.Four fold-lines were noted on the balloon at 3.5cm, 5cm, 6.4cm and 7.5cm from the catheter connection.The port was returned with approximately 34cm of catheter attached.The tubing strain relief was returned and was found along the middle of the catheter.The locking connector was in place in locked position.Biological debris was evident on and around the port.The lot number on the port was noted as zkbbfz.A dark grey colored substance was evident inside the catheter.A persistent crease was evident on the catheter at 1.2cm away from the locking connector.The port was received with the catheter around the port and the catheter bent where the crease is evident, and a break in the consistency of the material of the catheter was noted along the crease.A functional leak tests were performed on the band and the catheter and no leak was evident.The complaint cannot be confirmed.Product analysis cannot confirm events that are physiological in nature.The returned velocity injection port was visually inspected, it was noted that there were no anomalies with respect to the device appearance.A kink in the catheter was observed.However, this observation is not related to the reported event.While it is not possible to draw a definitive conclusion regarding root cause of the reported event, vomiting is a recognized adverse event associated to gastric banding.The product's instructions for use (ifu) provides detailed information on potential causes and consequences.A device history record (dhr) review was carried out and no discrepancies were recorded on the file in relation to this event.

• Brand Name: REALIZE ADJ GASTRIC BAND
• 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: 4848606
• MDR Text Key: 5944420
• Report Number: 3005992282-2015-00026
• 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: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

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: 10/01/2014
• Device Catalogue Number: RLZB22
• Device Lot Number: ZKBBCF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2009
• 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