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

Catalog Number RLZB32

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Blood Loss (2597); No Code Available (3191)

Event Date 03/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformances.

Event Description

It was reported that after the placement of a realize band the device had prolapsed.The patient had the device place in (b)(6) 2013.In (b)(6) 2014 the patient had the flu and pneumonia and subsequent vomiting which caused the device to prolapse.This diagnosis was confirmed in (b)(6) 2014.The patient had another surgery at this time for the band issue.During this procedure a hiatal hernia was repaired, scar tissue was cleaned and the surgeon fractured the patient's liver.This led to the patient bleeding and receiving 4l of fluids.The patient reported that the surgeon told her that her band had been replaced with a new band.However, the patient later found out that the surgeon kept the same device in the patient.Recently, the patient experienced some vomiting and afterwards felt some tightness at the base of her esophagus.Also, the patient had swelling of her tongue and a scratchy throat.The patient thought this may have been due to esophageal fluids entering her mouth.The patient tried prilosec for a week and the swelling of the tongue decreased.The patient also slept with 3 pillows.The patient had an upper gi and the results were that no proximal pouch was seen.While seeing a different doctor than the surgeon who did the initial and second surgeries, a physician's assistant removed 2cc from the band and the constrictive feeling at the base of her esophagus decreased.The patient is scheduled for an egd on (b)(6) 2016.The patient also reported that she has recently been diagnosed with multiple myeloma and was concerned that the plastic substance in the band may have contributed to this issue.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the first band the surgeon used suture to anchor.The second one they used hooks and it was placed up much higher.At the time of the second procedure, the patient was at (b)(6).In the second procedure, the op-notes read the band was re-positioned and checked for leaks.It is unclear if a new band was placed or if the original one was just re-positioned.The op-notes also states they had a fundoplication performed in the second procedure.As far as diagnostic testing, they have had a cat scan and upper gi.An egd was performed on the (b)(6) and the results showed the band looked fine.According to their op-notes, it is 2 cm away from the junction.Per the patient, they lost 60lbs with the first band.Since all the complications, they are now at 215 lbs.The band had a max.Of 10-10.5 cc at one time.Currently the band has 1 or 1.5cc remaining in it.

• 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: 5316420
• MDR Text Key: 34071552
• Report Number: 3005992282-2015-00051
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1