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

Catalog Number RLZB32

Device Problems Kinked (1339); Malposition of Device (2616); Improper Device Output (2953)

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

Event Type  malfunction  

Event Description

It was reported that post implant a realize band, (b)(6) 2012.5 cc was added and then another 3 cc but was not able to get the fluid back.(b)(6) 2012 fluid was added, but was getting back less than what was added.Patient sent for x-ray and no leak was found.The surgeon believed the there was an issue with the port.(b)(6) 2012 the patient was taken back to have the port repositioned and a kink was removed.The tubing was not trimmed and it was reconnected to the port.(b)(6) 2012 an adjustment was done everything seemed ok.(b)(6) 2013 added 2cc and felt that amount added did not appear to be holding.The patient continues to experience problems with restriction throughout the year.(b)(6) 2013 surgeon continues to get out less than what he believed to have been added.Th was determined by using he medical notes an adding to the previous amount.The surgeon now withdraws all of the fluid before adding, but still has a discrepancy in what he feels should be the total amount in the band.The ecs medical director recommended checking for a recurring kink and replacing the port.Surgeon to contact the patient to do further diagnostic test and recommend having the port replaced.

Manufacturer Narrative

(b)(4).Device remains implanted.

• 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: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 3553664
• MDR Text Key: 4099114
• Report Number: 3005992282-2014-00001
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Other Device ID Number: BATCH #: UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2013
• 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