D
Patient 1
HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND SYSTEM PORT THAT "HAS A KINK IN THE TUBING."
MAUDE MDR 4684276
- MDR report key
- 4684276
- Report number
- 3006722112-2015-00119
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-02-12
- Date received
- 2015-04-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LEBEOUF
- Address
- 1120 S CAPITAL OF TX HWY BLDG 1, STE 300 AUSTIN TX 78746 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-09 | 0 |
Event Narratives#
N
Patient 1
TAPER UNKNOWN. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT AND IMPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE CATALOG NUMBER, SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. DEVICE LABELING ADDRESSES THE FOLLOWING PRECAUTION TO PREVENT A FOLD IN THE TUBING: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR ACCESS PORT TUBING, WITHOUT SHARP.
N
Patient 1
THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. OBSTRUCTION, POUCH DILATION, BAND SLIPPAGE, VOMITING AND NAUSEA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.
D
Patient 1
ADDITIONAL FINDINGS HEALTHCARE PROFESSIONAL REPORTED, "COULD NOT FILL BAND. FOUND TUBING LEAK ON FLUOROSCOPY. FOUND BREAK IN TUBING AT PROXIMAL END." PORT AND TUBING WERE REMOVED AND REPLACED. PT UNDERWENT A PREVIOUS BAND REVISION SURGERY FOR PROLAPSE DUE TO DIAGNOSTIC FINDINGS OF "DILATATION OR SLIPPAGE," "ACUTE OBSTRUCTION," AND "A LARGE PROXIMAL GASTRIC POUCH" AND PRESENTED "NAUSEA" AND VOMITING" "KINK IN TUBING" WAS NOT CONFIRMED BY HEALTHCARE PROFESSIONAL.
N
Patient 1
TAPER II. MEDWATCH SENT TO FDA ON 07/27/2015. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED A THINNER SURFACE AND SMOOTH OPENING AT THE TAPER TUBING JUNCTION CONSISTENT WITH WEAR AND TEAR. ANALYSIS NOTED THE BAND TUBING AND TAPER TUBING JUNCTION WERE BROKEN WITH CURVED STRIATIONS CONSISTENT WITH SURGICAL END CUTS FOR THE REMOVAL OF THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE." "CAUTION: WHEN ADJUSTING BAND VOLUME, USE OF AN INAPPROPRIATE NEEDLE MAY CAUSE ACCESS PORT LEAKAGE AND REQUIRES RE-OPERATION TO REPLACE THE PORT. USE ONLY LAP-BAND SYSTEM ACCESS PORT NEEDLES. DO NOT USE STANDARD HYPODERMIC NEEDLES, AS THESE MAY CAUSE LEAKS."