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

Catalog Number BD2XV

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 10/14/2013

Event Type  malfunction  

Event Description

It was reported post implant a swedish band placed in 2004, the band was replaced on (b)(6) 2006 as it was leaking and a hole was found in the balloon.Patient returned (b)(6) 2013 and an adjustment was unsuccessful.A ct scan showed the band to be leaking.The band was removed and a hole was found in the balloon for a second time.

Manufacturer Narrative

(b)(4): information unavailable.

Manufacturer Narrative

(b)(4).Additional information: upon visual inspection a small tear was observed on the balloon near the fold line.It can be suggested that the tear was linked to a general deterioration of the balloon over time.The product's instructions for use (ifu) were reviewed with respect to balloon leakage and it is noted that band leakage is a recognized event associated with gastric banding, it was also noted that leakage can occur following poor handling of the balloon during surgery, or as a result of filling it with the wrong type of filling solution or general deterioration of the balloon over time.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process in relation to the alleged issue.A review of the manufacturing process was performed and it is noted that all products are 100% leak tested prior to release, therefore it is unlikely that a manufacturing issue contributed to the reported event.

• 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: 3568579
• MDR Text Key: 4214170
• Report Number: 3005992282-2014-00003
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2013

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 Expiration Date: 09/30/2016
• Device Catalogue Number: BD2XV
• Other Device ID Number: BATCH #: 09180603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 01/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2011
• 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