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

Catalog Number BD3XV

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.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.(b)(4).

Event Description

It was reported that after a laparoscopic gastric banding procedure, on the eighth day, the patient complaining of pain in the stomach.Ct with contrast was conducted, where it was revealed flow of contrast into the peritoneal cavity at the site of the projection band.The patient was hospitalized and operated on again with the removal of the band with wedge resection of gastric suturing the stomach wall defect by means of wedge resection of the stomach defect.During the operation, identified decubitus front wall of the stomach in place of the projection band.

Manufacturer Narrative

(b)(4).The curved band, velocity port and locking connector without the tubing strain relief were returned.Upon visual inspection, the curved band was returned in closed position; however it was observed that the buckle tongue was not correctly placed in the locking shell.Several yellow stains were observed on the locking connector.The velocity port was returned with the hook retracted, the actuator ring was in unlocked position.Upon microscopic evaluation no puncture was observed on the septum.A leak test was performed on the band/balloon, with successful result; no leak noted.A functional test was performed on the velocity port with successful result; hooks were deployed and retracted correctly.Dimensional analysis of the returned components was performed with respect to tubing connection.The product components meet the specification requirements.While it was not possible to draw a definitive conclusion regarding the root cause of the reported event, it was observed within the product's instruction for use (ifu) that erosion and port disconnection are recognized adverse events associated with adjustable gastric band.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process in relation to the alleged issue.

• Brand Name: ADJUSTABLE GASTRIC BAND
• 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: 5030894
• MDR Text Key: 24048115
• Report Number: 3005992282-2015-00040
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/04/2015

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 Expiration Date: 02/29/2020
• Device Catalogue Number: BD3XV
• Device Lot Number: ZTDBBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1