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

Catalog Number SAGBX

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/02/2015

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, there was a report of leaking sagb, gastric band.The patient was being operated on ((b)(6) 2015) now with replacement product (sagb).Adverse event to patient unknown.Delay in surgery unknown.

Manufacturer Narrative

(b)(4).Information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.The following information was requested, but unavailable: what is the patient¿s current status? when did the leak occur? had the band been implanted and later a leak discovered? or was a leak detected during implantation? how was the leak detected? was the band leak tested prior to implant? what size trocar was used during implantation? can the lot number / product code of the discarded device be provided? what is the implant date for the band that was discarded? please provide details of fills to date (amounts/ dates)? was the band filled to maximum capacity?.

Manufacturer Narrative

(b)(4).Additional information: upon visual inspection of the band, it was observed that the buckle on the band was cut, and discoloration of the band was evident.The band was returned with 28.5cm of catheter tubing.Six fold lines were observed on the band and were found at 3cm, 4cm, 4.5cm, 5cm, 6cm and 7.5cm, from the catheter connection.One perforation was evident on the side of the first fold line at 3cm.A disconnect of the base of the catheter tubing on the reinforcement of the band at the buckle end was observed.However, no perforations were visible.A leak test was performed and bubbles were observed where the perforation was visible at 3cm from the catheter connection.While it is not possible to draw definitive conclusions regarding root cause, the appearance of small perforation along the material fold lines would suggest that the perforation originated from a point of material degradation on / near a fold line.The presence of fold lines is associated with the wear and tear of the implanted band.However, it is also noted that the product's instruction for use (ifu) cautions against inadvertent perforation of the band from sharp instrumentation during implant.Such perforations may also lead to leakage.Based on the above, it was tentatively concluded that the observed perforations were most likely the result of material degradation and subsequent leakage on or near a product fold line consistent with the reported implant time.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process, therefore, a manufacturing issue was unlikely to have contributed to the reported event since 100% of devices are leak tested prior to lot release.

• 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: 4698871
• MDR Text Key: 5723898
• Report Number: 3005992282-2015-00014
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2005
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1