MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Model Number C-20365

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Event Description

After local anesthesia, a rupture between the union of the tube and the reservoir was observed in the opening of the system, not in the union of the reservoir tube with the band tube, but in the union of the reservoir tube with the reservoir itself.Never has sensation of having the band - never feels full.Finally had the system tested and it was proven there is a leak in the system by puncture.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): APOLLO ENDOSURGERY; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: kristin wielenga ; 1001 calle amanecer; san clemente, CA 92673
• MDR Report Key: 9177345
• MDR Text Key: 194511149
• Report Number: 3013508647-2019-00054
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2019

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 Model Number: C-20365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 40 YR
• Patient Weight: 100