MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  malfunction  

Event Description

It was reported that at an unknown time for an unknown procedure, ruptured port.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Date sent: 8/15/2016 - band extender for bd3xv received.No other components were received.Visual inspection identified that the extender received is, as it appears in the photo previously provided.A tear is evident down the center of the extender where the suture is housed.It was observed under microscope that the rupture of the silicone is along the location of the suture.The suture remains intact and has become free from the right side of the component.The left side of the suture remains embedded in the silicone.The tear along the component does not appear consistent with a cut from a sharp instrument as the suture remains in-tact.It suggests that an excessive lateral force was applied on the suture during the placement.No functional analysis can be performed.A dhr was performed and no discrepancies were recorded.All devices are 100% inspected prior to release.

• Brand Name: GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
• 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-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5812271
• MDR Text Key: 50963612
• Report Number: 3005992282-2016-00035
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: BD3XV
• Device Lot Number: ZVCBC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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