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

Catalog Number BD3XV

Device Problem Disconnection (1171)

Patient Problems Failure of Implant (1924); Surgical procedure (2357)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

It was reported that the connector on the gastric band became disconnected after approximately five years in the patient.The gastric band was removed.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information unavailable.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.Additional information was obtained: the surgeon confirms that after he found the first disconnection, he replaced the port after this disconnected for the 2nd time, the patient no longer wanted a band and surgeon did a bypass the following information was requested, but unavailable: what is the exact date the band was implanted? was the band removed on (b)(6) 2015? if not, what date was it removed? has the patient had any adjustments or has the port been accessed? how was the port disconnect detected? when the band was removed, was the locking connector attached to the port? was it locked? where was the strain relief?.

• 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: 4775535
• MDR Text Key: 19405822
• Report Number: 3005992282-2015-00023
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BD3XV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 05/15/2015
• 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