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

Catalog Number BD3XV

Device Problem Fitting Problem (2183)

Patient Problem Surgical procedure, additional (2564)

Event Date 07/30/2014

Event Type  malfunction  

Event Description

It was reported that after a gastric band procedure, the surgeon has been unable to adjust the band.He has tried several times, including intra-operative investigation.Patient is going back into theatre on (b)(6), 2014.

Manufacturer Narrative

(b)(4): information asked for but unknown or not provided during initial contact.Should the information be provided later, a supplemental medwatch will be sent.Responses received from additional information requested: what is the patients current status? ¿ band still in place, port revised and repositioned for easier access.Was the adjustment performed under fluoroscopy? ¿ yes, band filled and emptied normally, band and port fully functional.Will the band be explanted? if so, will the band be returned for evaluation? - no what is the lot number of the product? ??? has the port flipped preventing access to the port and therefore preventing band adjustment? - no.Has a port disconnection been noted? ¿ no.This does not appear to be a product complaint, more a technical error filling the band.

• 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: 4242364
• MDR Text Key: 5064982
• Report Number: 3005992282-2014-00062
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• 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
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BD3XV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1