MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND AP LARGE W/ ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number	B-2245
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown taper.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed only the lap-band was received.The taper type was unable to be confirmed.The end plug was present at the end of the band tubing.The end plug was connected to the end of the band tubing by the ss connector.White particles were noted to be on the inner surface of the band shell.Portions of the band ring and shell were noted to be discolored, as they were light yellow.A port leak test and a fill inspection test were not feasible as the port was not returned.An air leak test was performed and leakage was observed on the band shell approximately 1.5 inches from the band belt.Under microscopic analysis the opening on the band shell was approximately.1 inches in length.The apparent origination point of the opening was noted to have striated edges, consistent with damage from a surgical tool.The end of the band tubing was observed to have striated edges, consistent with a surgical end cut to remove the device.One non-penetrating nick was observed on the band belt.  device labeling addresses the reported event as follows: precautions: 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.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.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warnings: patients should be advised that the lap-band system is a long-term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.
Event or Problem Description
Reported as: a patient with the lap-band system was reported to have an "issue with one of the lap-bands." additional information noted the patient experienced a leak.The device was removed and replaced.

• Brand Name: LAP-BAND AP LARGE W/ ACCESS PORT I
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 8405654
• Report Number: 3013508647-2019-00012
• Device Sequence Number: 389088
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: 10811955020190
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: 08/04/2013
• Device Model Number: B-2245
• Device Catalogue Number: B-2245
• Device Lot Number: 2156303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 115