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

Catalog Number BD3XV

Device Problem Premature Activation (1484)

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

Event Date 12/03/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the band was received along with 60cm of catheter attached with the one way valve inserted in the catheter.The lot number etched on the curved band is h51z52.The port was received with the red safety cap on, lot number zmjbbp and the port applier.The tubing strain relief, locking connector and extender tab was not returned.Per visual inspection: a cut where the extender tab would have been attached was evident on the band.This is a "clean cut¿ suggesting this may have been cut with a sharp medical instrument.The curved band showed no defects upon visual examination or during leak testing.The port was tested with the returned applier and again with another unused applier and was found functional.The complaint was not confirmed, device was returned fully functional and relevant dimensions met specification.

Event Description

It was reported that during a gastric band procedure, the port on the band snapped prematurely while inserting.New port was requested.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4): no device received for analysis at time of submission of 3500a 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: 4341766
• MDR Text Key: 18118862
• Report Number: 3005992282-2014-00071
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2014

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: 08/31/2016
• Device Catalogue Number: BD3XV
• Device Lot Number: ZMMBB6. ZMMBB5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1