MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

It was reported that after an unknown procedure, when the patient came for a band adjustment, the port was dislocated.The surgery was done to fix it back, but the legs of the port were half open and didn¿t fix.The port was replaced by a new one.The patient got the band in (b)(6) of 2009.There were no adverse consequences for the patient reported.

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

(b)(4).Additional information: hook tip ben, biological debris presence.Batch # zkbbnk the port, locking connector and tubing strain relief were returned (in three pieces).The underside of the port was returned with several scratch marks.The lot number remained visible - zkbbnk.The port was returned in unlocked position.The 3 of the 4 hooks were slightly deployed when the port was in unlocked position.The 3 of the 4 hook tips appeared to be bent.The port was tested for hook deployment.A sample port applier was used to deploy the port hooks.During the first attempt, the hooks did not deploy as intended; the hooks partially deployed.Upon the second attempt, some resistance was felt however the hooks deployed.It was observed that the hook ends were slightly bent.The velocity port was then disassembled to determine the position of the staples and the status of the hooks.Upon initial separation of the actuator ring from the port body, the location of the staples appeared correct and consistent for all four staples.Biological debris was evident inside the port.Some of the biological debris was removed and the port reassembled.After reassembly of the port, the hook deployment test was undertaken again with a positive result - the hooks could be deployed.The septum of the port was examined under microscope.5 punctures were visible in the septum.Needle punctures were also visible on the underside of the port.It is difficult to determine how many needle punctures are present on the underside (where the lot number is engraved) due to the amount of scratches visible.The port has been implanted since 2009.It would normally be expected to see more punctures on the septum under microscopic view for a port which has been implanted for 6 years.The scratches on the underside of the port are consistent with scratches as a result of needle use, in a possible attempt to fill the band.Contributing factors to port displacement include patient physical activity, port location and improper port anchoring.While it is not possible to draw definitive conclusions regarding root cause of the reported events, it is noted that port migration / port flip are recognized events associated with gastric banding and the realize adjustable gastric band.Its causes and consequences are outlined within the products' instructions for use (ifu).A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process.Review of manufacturing process was performed and it was noted that injection ports are 100% functionally tested prior release; therefore it is unlikely that a manufacturing issue contributed at this event description.

• 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: 4891626
• MDR Text Key: 6831042
• Report Number: 3005992282-2015-00032
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: LG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: BD3XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1