FDA.reportPublic FDA data

MAUDE MDR 8441310

MDR report key
8441310
Report number
2015691-2019-00975
Event key
0
Event type
3
Date of event
2019-01-22
Date received
2019-03-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LYNN SELAWSKI
Address
1 EDWARDS WAY IRVINE CA 92614 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETERSWAN-GANZ CATHETEREDWARDS LIFESCIENCES, PRDQE777F8777F861579280R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-210

Event Narratives#

N

Patient 1

ONE CATHETER WITH ATTACHED MONOJECT 1.5 CC VOLUME LIMITED SYRINGE AND TWO THREE-WAY STOPCOCKS WAS RETURNED FOR EVALUATION. A NON-EDWARDS CONTAMINATION SHIELD WAS LOCATED ON THE CATHETER BODY BETWEEN 68 CM AND 84 CM PROXIMAL FROM THE CATHETER TIP. BALLOON DID NOT INFLATE DUE TO LEAKAGE FROM A TEAR, APPROXIMATELY 0.5 MM X 5 MM, AT THE CENTRAL SIDE OF THE BALLOON LATEX. THE LATEX EDGES WERE NOT ABLE TO MATCH UP. NO VISIBLE DAMAGE WAS NOTED ON THE CATHETER BODY UNDER THE BALLOON LATEX. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO OTHER VISIBLE DAMAGE OR ABNORMALITY TO THE CATHETER BODY OR RETURNED SYRINGE WAS OBSERVED. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.5 CC AIR BY HOLDING THE BALLOON UNDER WATER. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT MAGNIFICATION 20X. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. CUSTOMER REPORT OF BALLOON INFLATION ISSUE WAS CONFIRMED DURING THE ANALYSIS. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED, BEFORE DECIDING TO INSERT OR USE THE CATHETER, TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE TECHNIQUES FOR INSERTION, METHODS OF USING THE CATHETER TO OBTAIN PATIENT DATA INFORMATION, AND THE OCCURRENCE OF COMPLICATIONS IS WELL DESCRIBED IN THE LITERATURE. IT IS COMMON CLINICAL PRACTICE TO CHECK BALLOON INTEGRITY BY INFLATING IT TO THE RECOMMENDED VOLUME IN ORDER TO DETECT ANY ASYMMETRY OR LEAKAGE CONDITION BEFORE USE OF THE CATHETER. IT IS UNKNOWN IF USER OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS INCIDENT OCCURRED BEFORE USE SO THERE WAS NO PATIENT COMPROMISE NOTED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

D

Patient 1

IT WAS REPORTED THAT THE BALLOON OF THE SWAN GANZ CATHETER DID NOT INFLATE BEFORE USE. PATIENT DEMOGRAPHIC INFORMATION REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.