MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SWEDISH ADJUSTABLE GASTRIC BAND; LTI IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Fistula (1862)

Event Date 06/02/2014

Event Type  Injury  

Event Description

It was reported that post implant of the realize adjustable band, the band was removed.During removal they found that the buckle was posterior on the stomach and had eroded into the pancreas.This caused a fistula in pancreatic duct.

Event Description

The patient has been discharged home from the hospital.Exact discharged date unknown.

Manufacturer Narrative

(b)(4): information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.Which realize band did the patient have implanted? realize is all he knows.What was the date of implant? unknown, he did not do the orginal procedure what was the exact date the band was explanted? (b)(6) 2014.Is there a lot number available? no.Is the band available to be returned for evaluation? no.How many fills/adjustment had the patient had? patient could not tolerated refills, the band was empty.What technique was used to secure the band in position? unknown.This band was orginally placed by a surgeon who has since moved out of state.A different surgeon removed the band.The patient has been in the hospital for 5 weeks.

Manufacturer Narrative

(b)(4).

• Brand Name: SWEDISH ADJUSTABLE GASTRIC BAND
• Type of Device: LTI 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: 3953300
• MDR Text Key: 4646298
• Report Number: 3005992282-2014-00042
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 07/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1