FDA.reportPublic FDA data

MAUDE MDR 5501378

MDR report key
5501378
Report number
1649914-2016-00006
Event key
0
Event type
3
Date of event
2016-02-23
Date received
2016-03-15
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
MRS. AMY CLENDENING-WHEELER
Address
ONE ALLENTOWN PARKWAY ALLEN TX 75002 US
Phone
972-972-9723
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SADDLELOOPMANUAL SURGICAL INSTRUMENT (CLAMP, RETRACTOR)QUEST MEDICAL, INC.GAE15410499345C01Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-1501. R

Event Narratives#

N

Patient 1

VISUAL EXAMINATION OF THE COMPLAINT SAMPLE CONFIRMED THE ALLEGED COMPLAINT CONDITION. INSUFFICIENT ADHESIVE AND/OR INADEQUATE ADHESIVE-CURING TIME APPEARS TO HAVE RESULTED IN THE TENSIONER TO COME OFF THE DEVICE DURING USE. THERE ARE NO MORE DEVICES OF THIS LOT REMAINING IN INVENTORY FOR ADDITIONAL ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

D

Patient 1

THE HOSPITAL SUPPLY CHAIN COORDINATOR REPORTED AN ISSUE WITH THE SADDLELOOP DEVICE DURING USE. THEY REPORTED THAT DURING AN OPEN-HEART PROCEDURE THE PLASTIC LOCKING MECHANISM POPPED OFF AS SOON AS IT WAS CINCHED DOWN ON THE VESSEL. THE REPORT STATED THE SURGEON HAD TO "IMPROVISE" TO COMPLETE THE PROCEDURE. THE COMPLAINANT REPORTED THE ISSUE HAS OCCURRED BEFORE IN PRIOR SURGERIES BUT THEY ARE JUST NOW REPORTING IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.