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

Catalog Number RLZB22

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It was reported that the patient had a band placed in 2008.The band was removed and converted to a roux-en-y on (b)(6) 2014.During this procedure it was reported that the rubber piece on the locking connector was not present and could not be found.It was also reported that it did not seem like the tubing was connected to the port.It was reported that it was not known if this disconnection occurred during the roux-en-y procedure or at some time previous to the procedure.The surgeon searched for the rubber piece through-out the procedure and additionally for 1 hour at the end of the procedure.The rubber piece was not found.It was not known if the rubber piece had been lost during the procedure or at some time previous to the procedure and encapsulated inside the patient.The patient was closed and all vitals were good.

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.

Manufacturer Narrative

Upon further review of the information provided, it was concluded that this event does not meet the fda defined criteria for a serious injury, and is being considered a malfunction.

Manufacturer Narrative

(b)(4).Additional information the components were returned as follows: the straight band (band /balloon) with 52cm of catheter and the velocity port with locking connector.The tubing strain relief (tsr) was not returned for evaluation.Upon visual inspection it was noted that the buckle of the reinforcing band was cut on one side.Biological debris was observed inside the balloon (the liquid in the band was yellow).The actuator ring from the velocity port was in locked position, and hooks were deployed.The locking connector was in unlocked position.Upon microscopic evaluation, it was noted that the septum had been punctured 8 times.It is also noted that the tubing connection had been crushed (probably damage caused by a grasper).Dimension measurements around the locking connector and tubing connection were performed and found to meet specification.A leak test was performed on the band/balloon with a successful result, no leak was noted.A leak test was performed on the injection port with a successful result - no leak observed.Damage observed on the barb of the port is most likely due to damage caused by a grasper which is most likely to have occurred during explantation of the device.Nevertheless, measurement on the bard meets the specification requirements.While it is not possible to provide a definitive conclusion regarding the root cause of the reported event, it is noted that port disconnection is recognized as an adverse event associated with gastric banding.Its causes and consequences are outlined within the products instructions for use.

• 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: 4379287
• MDR Text Key: 5238529
• Report Number: 3005992282-2015-00001
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 46 YR