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

Model Number C-20365

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2020

Event Type  malfunction  

Event Description

Leak from the port connector where tubing was joined to the port and which had separated due to the tube having been stressed by sharp angulation.Port removed.Xray performed and showed contrast leakage around the port site.System flushed.Apl port replaced.Nurse and patient contact, loss of restriction and fluid found cloudy and bubbly.Xray performed and showed contrast leakage around the port site.

Manufacturer Narrative

Investigation results: the reported complaint for leak and broken strain relief were confirmed.The cause of the leak was a hole in the tubing at the port stem likely caused by the detachment of the strain relief.The cause of the detached strain relief is a deformed port connector.The cause of the deformation was not determined.The port lhr was reviewed and no discrepancies or non-conformances recorded.Port was manufactured according to specification.

• 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: 11385907
• MDR Text Key: 239129407
• Report Number: 3013508647-2021-00004
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: C-20365
• Device Catalogue Number: C-20365
• Device Lot Number: AF02264
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 100