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

Device Problem Material Rupture (1546)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 03/25/2021

Event Type  malfunction  

Event Description

Surgeon replaced lap-band due to ruptured tubing.Confirmed by follow up at xray.Device implanted (b)(6) 2008.

Manufacturer Narrative

Unable to determine in a laboratory setting why the rupture occurred, however the complaint is confirmed.There were no visible leaks, fractures or wear visible on the band.The complaint investigation was inconclusive regarding the reported complaint and a root cause was not identified.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.The lot history record for the band and port lot was not available to be reviewed.Unable to determine root cause.A potential root cause was not determined.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 11754328
• MDR Text Key: 255128918
• Report Number: 3013508647-2021-00015
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention