MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-18 for LAP-BAND AP SMALL SYSTEM WITH RAPIDPORT EZ C-20360 manufactured by Reshape Lifesciences.
[139098600]
Taper - rapidport ez strain relief. The reporter of the event was asked to return the product for analysis. To date, apollo has not received the device. Based on the serial number provided, the connecter type is assumed to be a taper rapidport ez strain relief. If returned, visual examination may confirm or determine another taper type associated with this event. Device labeling is addressed as follows: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant. 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. When adjusting band volume after the septum is punctured, do not tilt or rock the needle, as this may cause fluid leakage or damage to the septum. 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. Deflation of the band may occur due to leakage from the band, the port or the connecting tubing. Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended. Nausea and vomiting may also be symptoms of stoma obstruction or a band/stomach slippage. Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation. Deflation of the band is immediately indicated in all of these situations. Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting. Reoperation to reposition or remove the device may be required. Warnings: patients should be advised that the lap-band ap? System is a long-term implant. Explant 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.
Patient Sequence No: 1, Text Type: N, H10
[139098601]
Reported as: a patient with the lap-band system had fractured port tubing found during pre-operation computerized tomography (ct) scan and confirmed the stainless steel connector had become detached at the site during device removal. The device's free intraperitoneal end was lying free in the left upper quadrant (with fibrosis and neo-peritoneum coating the fractured surface. Only three inches of tubing was connected to the subxiphoid port. Patient struggled and failed to lose any weight. Device was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013508647-2019-00008 |
| MDR Report Key | 8428972 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-18 |
| Date of Report | 2019-09-12 |
| Date of Event | 2018-06-08 |
| Date Mfgr Received | 2019-09-12 |
| Device Manufacturer Date | 2015-10-27 |
| Date Added to Maude | 2019-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KRISTIN WIELENGA |
| Manufacturer Street | 1001 CALLE AMANECER |
| Manufacturer City | SAN CLEMENTE CA 92673 |
| Manufacturer Country | US |
| Manufacturer Postal | 92673 |
| Manufacturer Phone | 9494817851 |
| Manufacturer G1 | ALLERGAN |
| Manufacturer Street | GLOBAL PARK FREE ZONE 900 GLOBAL PARK |
| Manufacturer City | LA AURORA DE HEREDIA, |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP-BAND AP SMALL SYSTEM WITH RAPIDPORT EZ |
| Generic Name | ADJUSTABLE GASTRIC BAND |
| Product Code | LTI |
| Date Received | 2019-03-18 |
| Model Number | C-20360 |
| Catalog Number | C-20360 |
| Lot Number | 2824358 |
| Device Expiration Date | 2017-10-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE LIFESCIENCES |
| Manufacturer Address | 1001 CALLE AMANECER SAN CLEMENTE 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-18 |