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

Lot Number PORT LOT: 75EB3029

Device Problem Material Separation (1562)

Patient Problem Weight Changes (2607)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

A reporter sent an email to reshape customer service: "i'm contacting you today regarding an allergan gastric band recently explanted from a patient here at spire hull & east riding.The band appears to be ruptured/ fractured and the surgeon has requested that i report the issue.I have also attached a snippet of a ct scan report taken prior to the patients recent surgery, detailing the issue." "significant weight regain and loss of restriction after previous gastric band surgery.Ct (b)(6) 2022 shows connection of the intrabdominal tubing from band to filling port to have fractured and lying entirely out of continuity.".

Manufacturer Narrative

Complaint of a tubing fracture is confirmed.However, unable to determine root cause.The investigation found that the break in the tubing is slightly jagged and suggests that it was not cut.There are no signs of wear on the tubing at any point along the length of the tubing, including at/near the point of fracture.The lot history record for the band was not available to be reviewed by reshape as the serial number was not available.However, the port lot history record was reviewed and the device was manufactured to specification.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.Unable to determine root cause or conduct trending analysis.No further action to be taken.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: 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: 15465878
• MDR Text Key: 304977240
• Report Number: 3013508647-2022-00184
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: PORT LOT: 75EB3029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male