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

Model Number C-2304

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Abdominal Pain (1685)

Event Date 09/04/2020

Event Type  malfunction  

Event Description

Patient suddenly had severe pain in lower abdomen around (b)(6) 2020; ct scan was done.On (b)(6) 2020 physician looked at ct scan and saw lap band was broken.

Manufacturer Narrative

The port was examined and the complaint of detached tubing was confirmed.The detachment occured at the junction of the port taper and port tubing junction.There are signs of wear on the tubing segment that detached from the port and is evidence of a mechanical fatigue failure and not a manufacturing defect.Placement of the port and the angle of the tubing as it descends into the abdominal cavity is a potential cause of the wear.However, a 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: 11378634
• MDR Text Key: 233553192
• Report Number: 3013508647-2020-00033
• 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: 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

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: C-2304
• Device Catalogue Number: C-2304
• Device Lot Number: AF03452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100