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

Catalog Number RLZB22

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2015

Event Type  malfunction  

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.

Event Description

It was reported that the patient had a realize band placed (b)(6) 2008.Recently the patient had multiple fills with no restriction.The band was removed (b)(6) 2015.Upon removal it was noticed there was a hole in the band.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The straight band balloon was returned with the catheter and port attached.The tubing strain relief and locking connector were returned attached to the port.Visual inspection noted some debris, light yellow in color, was noted inside the balloon.The silicone of the lock end flat appeared to have been cut off and was not returned with the product (this most likely occurred to facilitate band removal)l; 7 fold-lines were present on the balloon at 3cm, 4cm; 4.5cm; 5cm; 6cm; 7cm & 8cm from the catheter connection.The balloon was leak tested.Air was emanating from the balloon.The balloon failed the leak test.The puncture was evident on the corner of the first fold line from the catheter connection and measured approximately 1mm.A review of the product's instruction for use (ifu) was performed and it is noted that balloon leakage is a recognized event associated with gastric banding and the realize band.Review of the products instructions for use also indicates that he manufacturer cannot assume any liability or responsibility for loss of the filling fluid resulting from improper handling and use, physiological reaction to the material, general deterioration of the balloon over time, or similar reasons.A device history record (dhr) review was performed, 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-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5008876
• MDR Text Key: 24603601
• Report Number: 3005992282-2015-00038
• 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,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/24/2015

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: 03/31/2013
• Device Catalogue Number: RLZB22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2008
• 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