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

Model Number	02-15149-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant stated, "he's only had his band less than a year.The system is not holding fluid and dr.Carter suspects fractured tubing.".No other relevant information was provided.
Additional Manufacturer Narrative
The company cannot verify the report and was unable to conduct further investigation.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided, as is.No information is available regarding the product that was involved.The lot history record for the complaint was not available to be reviewed.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.No new risks identified; the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.If additional information becomes available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.
Event or Problem Description
The doctor provided additional information: "the patient had been experiencing decreased restriction in his band and saline is not being retained in the band system.This indicates that the port is leaking or has malfunction such as fractured causing or tubing".
Additional Manufacturer Narrative
We found that the band tubing leaked when was irrigated with fluid under pressure.The leak was in the port tubing near the strain relief (armadillo).A puncture was observed in the port tubing near the strain relief.There are no other punctures or tears in any other parts of the tubing, and no other leaks were observed in the port.Therefore, the complaint was confirmed.Lot number 75da9087 was a sub-component of six different lap-band lots.All lot history records were reviewed.Records showed that all specifications were met, and quality inspections were passed.No nonconformances were recorded for these lots.The directions for use state that care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section of the band.The investigation findings do not lead to a clear root cause of the puncture.
Additional Manufacturer Narrative
Providing the gtin number related to this report.Only the catalog number was identified.No serial number was provided.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 7625 golden triangle drive; suite g; eden prairie MN 55344
• Manufacturer Contact: maria quiroz ; 7625 golden triangle drive; suite g; eden prairie, MN 55344 ; 8449377374
• MDR Report Key: 17927833
• Report Number: 3013508647-2023-00562
• Device Sequence Number: 6359030
• Product Code: LTI
• UDI-Device Identifier: 00850007764043
• UDI-Public: 00850007764043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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 Model Number: 02-15149-01
• Device Lot Number: 75DA9087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 08/09/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male