MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that a band implanted in a male patient in 2008 was reported as leaking.The surgeon performed a leak test with iv contrast, but was unable to find the source of the leak.The surgeon does not know what will be found when surgery is performed.This is all the information available at this time.

Manufacturer Narrative

(b)(4).Information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what date was the leak discovered? (b)(6).What were the events surrounding the leak discovery? no weight loss, reoperation etc? no weight loss.Was hungry and gaining weight.What is the patient s status? how has it been confirmed that there is a leak? persistent discrepancy in fluid received.What is the fill history? please note dates and the amount at each fill.On (b)(6) 2013 added fluid for total of 10.9.On (b)(6) 2015, complaining of increased hunger.Will the device be explanted? possibly based in surgical findings.Can the device be returned for investigation? if explanted.What is the lot number of the device? rlzb22, zjgbhk (zjgbhk) (b)(4) 2013.Implanted (b)(6) 2008.

Manufacturer Narrative

(b)(4).Additional information received: the surgeon is removing the band today ((b)(6) 2015).The surgeon did a methylene blue test through the port and placed a scope in the abdomen and a leak was confirmed.The surgeon has a new band in the room but it is unknown if the band will be replaced at this time.A dhr was carried out on final packaging lot number zjgbhk and 5 potential associated sub assembly lots ( zjgbdt, zjgbdm, zjgbdj, zjgbf0, zjgbfy) and no discrepancies were recorded on file.

Manufacturer Narrative

(b)(4): added additional information the product was received in good packaging.The band, port, locking connector, tubing strain relief and tubing (approx.43cm) were returned.Biological debris was evident on the port.The lot number engraved is zjgbh9.Buckle on the straight band was removed; this is likely due to surgeon removing the buckle to facilitate explant of the band.The balloon appears to have a blue tone in colo; 4 fold lines were identified on the balloon at approximately 3cm; 5cm; 6.7cm; and 7.7cm from the catheter connection.A leak was evident on the corner of the fold line situated at 3cm from the catheter connection.Per visual inspection, it was observed that the realize adjustable gastric band was returned with a small tear to the balloon, localized on a fold line.This was confirmed during leak testing.The tear was localized on the first fold line at 3cm from the catheter connection.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.A device history record (dhr) review was performed on final packaging lot zjgbhk and no discrepancies were observed during the manufacturing process.The manufacturing practices were reviewed and it was noted that all devices are leak tested prior to lot release.It is therefore considered unlikely that a manufacturing issue contributed to the reported event.

• 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: 4851741
• MDR Text Key: 18032304
• Report Number: 3005992282-2015-00027
• 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,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Catalogue Number: RLZB22
• Device Lot Number: ZJGBHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1