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

Model Number C-20360

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

The covering of the proximal tubing had fractured.Port replaced.Patient had review on (b)(6) 2020 and noted palpable prolapsed tubing from port would require resiting of the port to correct.

Manufacturer Narrative

Complaint for detachment of sheath around the strain relief is confirmed.The production records for the port was reviewed and no discrepencies or non-conformances recorded.Product was manufactured to specification.Unable to determine root cause.

• 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: 11385912
• MDR Text Key: 239124467
• Report Number: 3013508647-2020-00045
• 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

• 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: 08/26/2019
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Device Lot Number: AF01208
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 77