FDA.reportPublic FDA data

MAUDE MDR 4859188

MDR report key
4859188
Report number
3006722112-2015-00125
Event key
0
Event type
3
Date of event
2015-05-22
Date received
2015-06-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LAURA LEBOEUF
Address
1120 S CAPITAL OF TEXAS HWY BULDING 1, SUITE 300 AUSTIN TX 78748 US
Phone
855-855-8555
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)IMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTINAAB-202652635018Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-1801. O; 2. R

Event Narratives#

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTS: BAND LEAK, FRACTURED AT CONNECTION.

N

Patient 1

(B)(4). TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE.

N

Patient 1

TAPER II. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THAT THE TUBING AT THE PORT STAINLESS STEEL CONNECTOR WAS BROKEN THAT HAD A SHARP UNIDENTIFIED OPENING. 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: CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION."

D

Patient 1

HEALTH PROFESSIONAL REPORTS ON GASTRIC PORT: "FRACTURED TUBE ON PORT SIDE."

N

Patient 1

(B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THAT THE BAND TUBING OTHERS WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE 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: CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION."

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTS: BAND LEAK, FRACTURED AT CONNECTION.

N

Patient 1

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTS: BAND LEAK, FRACTURED AT CONNECTION.