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

Catalog Number RLZB22

Device Problem Human-Device Interface Problem (2949)

Patient Problems Vomiting (2144); Surgical procedure, additional (2564)

Event Date 11/14/2014

Event Type  Injury  

Event Description

It was reporte that the subject had esophageal dilation on ugi dated (b)(6) 2011.At this time, she began having fluid taken out of band.As dilation resolved with loosening, re-adjustment proved intolerable with vomiting and recurrent dilations.Ugi on (b)(6) 2014 showed tertiary waves and esophageal manometry revealed esophageal dysfunction/dysmotility.Band adjustment manipulation continued until november when subject and investigator determined the band would need to be removed.Planned surgical date ¿ (b)(6) 2014.

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.

Manufacturer Narrative

(b)(4).Additional information: the complaint cannot be confirmed.Product analysis cannot confirm events that are physiological in nature.The returned device was visually inspected, it was noted that per the analysis no anomalies with respect to device appearance.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process.While it is not possible to draw a definitive conclusion regarding root cause of the reported event, vomiting, intolerance, and esophageal distention or dilatation are recognized adverse event associated to gastric banding; the product's instruction for use (ifu) provides detailed information on potential causes and consequences.

• 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: 4316899
• MDR Text Key: 20453335
• Report Number: 3005992282-2014-00069
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: RLZB22
• Device Lot Number: ZKBBCF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1