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

Model Number C-20360

Device Problem Fluid/Blood Leak (1250)

Patient Problems Aspiration/Inhalation (1725); Insufficient Information (4580)

Event Date 02/06/2021

Event Type  malfunction  

Event Description

Leak test performed with methylene blue.Leak from the body of the port specially when the tube was stressed.Port removed.System flushed.Port replaced.Accessed port to perform adjustment.(b)(6) 2020 yellow fluid found.3mls in band - loss of 4.25mls.(b)(6) 2020 3.4ml straw colored fluid and froth aspirated.(b)(6) 2020 xray performed, only 2ml of murky yellow fluid found, so loss of 3ml.

Manufacturer Narrative

The observed failure appears to be consistent with an overlarge down-force application of mechanical stress to the tube at or near the external collar of the port housing.The lot history record for the band and for the port lot was reviewed and no discrepancies or non-conformances recorded.Product was manufactured according to specification.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: 11704081
• MDR Text Key: 250411307
• Report Number: 3013508647-2021-00012
• 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: 05/21/2021

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: 11/20/2019
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Device Lot Number: AF01529
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 83