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

Catalog Number BD3XV

Device Problem Disconnection (1171)

Patient Problem Surgical procedure, additional (2564)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

It was reported that during a gynaecological laparoscopy procedure, it was observed that the velocity port had come disconnected from the tubing within the patient.The port was replaced a tubing re-connected.Note that the locking connector (connecting device) was still attached to the port.This device was implanted on (b)(6) 2013.The patient had an x ray a year ago and the tubing was demonstrated to be connected correctly.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The following information was requested, but unavailable: what is the exact date the band was implanted? when the port has been replaced ? has the patient had any adjustments or has the port been accessed? how was the port disconnect detected? (x-ray, fluoroscopic, etc.) is this first incident of port disconnection? when the band was removed, was the locking connector attached to the port? was it locked? where was the strain relief? what is the final packaging lot number ? what is the patient status ?.

Manufacturer Narrative

(b)(4).The port was received with the locking connector and tubing strain relief (tsr) attached.The lot number etched on the port is zpbbb3.Biological debris was evident on the port.The tsr appears to have a blue tone in color.Biological debris was evident on the surface of the inner base of the locking connector and on the outer surface of the locking connector.The debris was removed to enable measuring of the inner diameter.Dimensional analysis was performed: inner diameter of locking connector (tubing end) = 4.06 mm (met specification).Outer diameter of connection tube = 2.75 mm (met specification).Several measurements around the tubing connection and locking connector were performed, and measurement met specification.The device was returned fully functional.A review of the instruction for use (ifu) was performed, and it was noted that the ifu provides specific instruction of how the connection of the components is to be made.Failure to connect the tubing per those instructions may result in a port disconnection.The ifu states: ¿slide the strain relief end of the locking connector onto the cut end of the sagb tubing.Allow the sagb tubing to pass approximately 2cm beyond the locking connector tab.Push the sagb tubing onto the connection tube that extends from the port until the tubing has reached the outer face of the connection housing on the port¿.A device history record (dhr) review was carried out on each lot number and no discrepancies were recorded during the manufacturing process in relation to the event.While it was not possible to draw a definitive conclusion regarding the root cause of the reported event, it is noted that port disconnection is a recognized adverse event associated with gastric banding and adjustable gastric band.

• 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-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4816607
• MDR Text Key: 5905886
• Report Number: 3005992282-2015-00024
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: BD3XV
• Device Lot Number: ZPDBBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1