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

Catalog Number BD3XV

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: product returned includes; port applier, port - lot # engraved zndbbp with red cap, curved band with locking connector still attached and 4 cm of catheter.Lot # zndbl6 and 57 cm of catheter with the one way valve.Upon visual inspection, it is noted that the catheter was cut in two distinct parts.The band was leak tested and no leakage has been observed.Device was returned fully functional, no leakage was observed.A device history record (dhr) review was performed, and no discrepancies were observed during the manufacturing process.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.No other investigation other than outlined within this file has been performed.

Event Description

It was reported that prior to a banding procedure there was a hole in the air pillow of the band.Procedure was completed with same like device.

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.

• 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: 4164272
• MDR Text Key: 12550687
• Report Number: 3005992282-2014-00057
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/30/2014

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: 04/30/2017
• Device Catalogue Number: BD3XV
• Device Lot Number: ZNFBCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2012
• 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