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

Model Number	C-2365
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported a port tubing dislocation in a patient that he implanted a new band system into one week ago.Patient lap band placed (b)(6) 2022 without issue, then 5 days later had pelvic pain and a ct at er showed disconnected tubing hanging in pelvis.
Additional Manufacturer Narrative
The observed failure appears to be consistent with an overlarge down or lateral application of mechanical stress to the tube at or near the external collar of the port housing.While it is impossible to know how the mechanical stress was exerted onto the access port, we do know that variations in port placement can be an issue.The instructions and illustration of optimal port placement are included in the lap-band systems instructions for use (ifu): failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen as shown in the diagrams below.No new risks identified, the current risk for this event is with a low rate of occurrence for the reported complaint category.No correction or corrective action required.The lot history record for the port lot and band was reviewed and no discrepencies or non-conformances recorded.Product was manufactured according to specification.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: maria quiroz ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 15108974
• Report Number: 3013508647-2022-00062
• Device Sequence Number: 4213631
• Product Code: LTI
• UDI-Device Identifier: 00850007764654
• UDI-Public: (01)00850007764654(17)231001(10)75HA6562(11)211001
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: C-2365
• Device Catalogue Number: C-2365
• Device Lot Number: 75HA6562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/01/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male