MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Split (2537)

Patient Problems Internal Organ Perforation (1987); Tissue Damage (2104)

Event Date 05/27/2014

Event Type  Injury  

Event Description

It was reported that during the placement of the realize adjustable band, the band was put in and as they were pulling it through to the other side to clip, the tip slit apart.They proceed to place and secure the band.The surgeon did a leak test and it was found that the patient has a leak in their stomach.The surgeon decided to remove the band.It will not be placed until the patient¿s stomach leakage has been dealt with.They used endo-stitch to close the defect.The realize dissector was used to dissect the retro gastric space.Patient had previous gastric bypass done several years ago.

Manufacturer Narrative

(b)(4): information was not provided by contact.The complaint cannot be confirmed.Product analysis of the returned device cannot confirm the reported event of gastric perforation.It is noted that gastric perforation is a recognized adverse event associated with gastric banding and the sagb vc product.A review of the product's instruction for use (ifu) was performed with regard gastric perforation.It is noted that organ damage has been reported to result from laparascopic placement of adjustable gastric bands and are considered to be potential complications of the sagb vc implantation.Precautions outlined for gastric perforation.A dhr review was performed and no discrepancies were noted during the manufacture of this band.

Manufacturer Narrative

(b)(4).Additional information: balloon perforation and damaged extender.

Manufacturer Narrative

Upon visual evaluation of the extender, it was noted that the black cutting indicator on the extender strap was torn.The tab tip was split.The measurement of the cut on the extender tip is 8.36mm.Leak testing as per procedure was not performed as a balloon perforation was clearly visible.Perforation was visible on the balloon just below the buckle area.The measurements of the cut under the buckle area are 8.15mm there is damage evident at the buckle area of the reinforcing band.While probable root cause cannot be determined, examination of the buckle area suggests that the buckle and underlying balloon was cut using a sharp instrument.This damage may have been caused on implantation and/ or explanation of the device.Product analysis of the returned device cannot confirm the reported event of gastric perforation.It is noted that gastric perforation is a recognized adverse event associated with gastric banding and the sagb vc product.Examination of extender indicated that damage was evident.While possible root cause cannot be determined, visual inspection indicates that excessive force may have been utilized on closing the band.The ifu clearly outlines procedure for correct band placement and closure.A review of the product's instruction for use (ifu) was performed with regards to gastric perforation.It is noted that organ damage has been reported to result from laparoscopic placement of adjustable gastric bands and are considered to be potential complications of the sagb vc implantation.Precautions outlined below are included within the products instructions for use, warning: remove any gastric tubes from the stomach before beginning dissection close to the stomach.Failure to do so may result in gastric perforation, particularly during posterior to the stomach.Caution: dissecting too close to the serosal surface of the stomach may increase the risk of band erosion or gastric perforation.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• 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: 3886889
• MDR Text Key: 19925252
• Report Number: 3005992282-2014-00032
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2014

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 Expiration Date: 10/31/2018
• Device Catalogue Number: RLZB32
• Device Lot Number: ZPNBBN
• Other Device ID Number: BATCH # ZPLBB2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 06/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2014; 04/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention