MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZPT2

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.At the time of this submission, the device has not been returned for analysis.The following information was requested, but unavailable: when was the band implanted? who did the implant? surgeon, resident, surgical assistant? has the patient had any adjustments or has the port been accessed? how many fills/adjustment has the patient had and the volume of each adjustment? who performed the adjustments? (surgeon, resident, surgical assistant)? was there any issue with accessing the port for the adjustments? is this first incident of port disconnection? how was the port disconnect detected? has any tests been performed to diagnose the issue? fluoroscopy/ endoscopy? if so, what testing and what were the results? what is the scheduled date of the revision? once the port has been removed; was the locking connector attached to the port? was it locked? where was the strain relief? what is the current status of the patient?.

Event Description

It was reported that following a gastric band procedure, the port is leaking; is believed to be defective, and the tubing has disconnected from the port.The surgeon does not think there are any issues with the band.It is unknown what tests have been performed to confirm.The surgeon plans to replace the port and reconnect the tubing.

Manufacturer Narrative

(b)(4).Additional information received: the patient had the reoperation to have the port replaced and rep was not notified of the date of reoperation at the time.When the rep tried to obtain the port for return, they were informed that the port was ¿crushed¿ by the surgeon during removal and subsequently disposed of by the account.Therefore, port will not be returning.

• Brand Name: REALIZE INJECTION PORT
• 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: 4681322
• MDR Text Key: 15374985
• Report Number: 3005992282-2015-00012
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZPT2
• Other Device ID Number: 20705036004018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1