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

Catalog Number RLZB32

Device Problems Device Slipped (1584); Malposition of Device (2616); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/20/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4): information anticipated, but unavailable at this time.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.(b)(4).

Manufacturer Narrative

(b)(4).Additional information: the band was received cut into, with 16 cm of catheter attached.The cut was made near the closed end of the band.Some bio debris was evident.No other punctures or tears were visible.The port was received with 7 cm of catheter attached.Bio debris was evident in and around the port.The actuator ring was in locked position and could not be moved manually.The complaint of band slippage cannot be confirmed as product analysis cannot confirm events that are physiological in nature.While it is not possible to draw a definitive conclusion regarding root cause of band slippage, it is noted that band slippage is a recognized adverse event associated with gastric banding and the use of the realize adjustable gastric band.A device history record (dhr) review was performed, and no discrepancies were noted on the file during the manufacturing process.

• 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: 4230591
• MDR Text Key: 12601291
• Report Number: 3005992282-2014-00061
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date: 10/20/2014

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: 11/30/2015
• Device Catalogue Number: RLZB32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 273