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

Catalog Number BD3XV

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that after an unknown procedure, the buckle broke off.No further details are available.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.

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.Additional information requested and received: sagb was implanted in (b)(6) 2011.During an ultrasound examination, a band defect was detected and a surgical procedure to remove the defect band was done at (b)(6) 2015.The patient is fine.

Manufacturer Narrative

(b)(4).Additional information: material separation of the tip of the locking shell.Implant date reported as (b)(6) 2011.Additional information was requested and the following was obtained: can you please supply details of the ¿band defect¿ that was detected during the ultrasound examination? four years after band implantation a band defect was detected during ultrasound examination.The broken buckle was recognized during explant surgery.Patient is fine.No further info is available.The following information was requested, but unavailable: was the buckle break recognized during the implant operation? was another same device used to complete the procedure? were there any consequences to the patient? what size trocar was the band placed through? were any difficulties experienced getting the band through the trocar? were any difficulties reported with band placement? has the patient had any adjustments? the band/balloon (lot #zlfbbv) was returned with approximately 57cm of catheter.The tubing strain relief was floating on the catheter.Some biological debris was found on the catheter and balloon; however no puncture or other damage was visible on the balloon.No damage around the buckle was observed.The event reported that the buckle broke off.The buckle of the band is intact and it is reasonably assumed that the complaint is regarding the separation of the locking shell at the balloon closed end.The tip of the locking shell has been returned separated from the device.Upon microscopic evaluation, a nick under the capital letter fb of the etch lot number was noted, this nick has been probably performed by a sharp instrument.It not possible to define if the nick was performed intra-op or post-op.While it is not possible to provide a definitive result for the reported event it is tentatively suggested that the device was inadvertently nicked/damaged during manipulation.This may in turn have caused the locking shell to tear after band placement procedure.Review of the product's instructions for use (ifu) indicates that the ifu cautions against damaging any part of the band, it is also noted that detailed instructions regarding proper device manipulation technique are provided.A device history record (dhr) review was carried out, and no discrepancies were recorded on file in relation to the event described.A review of the manufacturing process was performed and it is noted that all products are 100% visual inspected prior to release, therefore it is 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: 4706521
• MDR Text Key: 5718719
• Report Number: 3005992282-2015-00015
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: BD3XV
• Device Lot Number: ZLGBC8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1