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

Model Number C-20365

Device Problems Inability to Auto-Fill (1044); Break (1069); Complete Blockage (1094); No Flow (2991)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2020

Event Type  malfunction  

Event Description

Port and tubing would not fill at all.On post procedure, x-ray fill.Re-explantation, no outflow from port even after proximal tubing.Broken at port exit.

Manufacturer Narrative

The complaint is confirmed, there is a blockage in the septum cavity wall within the port that prevents fluid from being added or removed.

• 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: 11385905
• MDR Text Key: 239119965
• Report Number: 3013508647-2020-00047
• 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
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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 Expiration Date: 04/04/2020
• Device Model Number: C-20365
• Device Catalogue Number: C-20365
• Device Lot Number: AF01793
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR