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

Model Number	C-2360
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is pending return from the surgeon for investigation by manufacturer.
Event or Problem Description
Surgeon reported to sales representative that he suspects a leak in a lap-band system that he implanted.He has examined the port and port tubing and did not observe a leak.He suspects the leak is in the band tubing or the band itself.
Additional Manufacturer Narrative
The lhr for lot 75fa3106 was reviewed.The device was manufactured to specification and no deviations or ncmrs were noted related to device functionality.The returned device underwent air and water leak tests per wi0034 and extended water leak test for 48 hours.No evidence of gross leak was detected.A small tear was observed on the port sheath which showed no signs of leak.Leak testing was performed and documented.It is concluded that the reported leak is not attributed to device manufacturing and additionally is unlikely to be the result of user error.Review of the device design and materials revealed the most likely cause of the observed fluid loss is fluid permeation through the silicone component of the lap-band that receives the normal bolus of fluid when implanted or adjusted to decrease the inside circumference of this component of the lap-band.Some fluid loss from the lap-band is expected due to natural permeation through the silicone material.The dfu instructs the user to regularly adjust the amount of fluid in the device.Based on this, no corrective actions are required in response to this complaint.The failure mode of device leakage is addressed in the device risk management file, and the most recent complaints review demonstrates acceptable low rate of occurrence for leakage.Complaint rate for this category continues to be monitored.

• 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; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer Contact: maria quiroz ; 18 technology drive, suite 110; irvine, CA 92618 ; 8449377374
• MDR Report Key: 16773828
• Report Number: 3013508647-2023-00196
• Device Sequence Number: 12467608
• Product Code: LTI
• UDI-Device Identifier: 00850007764609
• UDI-Public: (01)00850007764609(17)230622(10)75FA3106(11)210622
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: C-2360
• Device Catalogue Number: C-2360
• Device Lot Number: 75FA3106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/13/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female