FDA.reportPublic FDA data

MAUDE MDR 8189891

MDR report key
8189891
Report number
2015691-2018-05514
Event key
0
Event type
3
Date of event
2018-08-23
Date received
2018-12-21
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. SAMANTHA EVELEIGH
Address
ONE EDWARDS WAY IRVINE CA 92614 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FOGARTY DILATION ATRIOSEPTOSTOMY CATHETERCATHETER, SEPTOSTOMYEDWARDS LIFESCIENCES, PRDXF830705F830705F61176182R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-210

Event Narratives#

N

Patient 1

OUR PRODUCT EVALUATION LABORATORY RECEIVED ONE MODEL 830705F CATHETER. THE BALLOON WAS INFLATED WITH 3.6CC OF AIR AND THE BALLOON INFLATED CONCENTRIC. BALLOON DEFLATION WAS ACHIEVED IN 4 SECONDS, WHICH WAS WITHIN THE MAXIMUM SPECIFIED DEFLATION TIME WITH AIR. THE BALLOON WAS AGAIN INFLATED USING 1.8CC OF WATER AND THE BALLOON INFLATED CONCENTRIC AND DID NOT LEAK. THE BALLOON COULD NOT DEFLATE COMPLETELY AFTER 15 SECONDS, WHICH WAS OUT OF THE SPECIFIED MAXIMUM DEFLATION TIME WITH WATER. THE BALLOON LATEX APPEARED DETERIORATED AND DISCOLORED ON THE EXPOSED BALLOON LATEX. THE BALLOON LATEX UNDER THE BALLOON WINDINGS APPEARED TO BE IN GOOD CONDITION. THE BALLOON WINDINGS AND BALLOON LATEX WERE REMOVED TO SHOW THE NYLON YARN UNDER THE BALLOON LATEX. AN UNKNOWN CRYSTAL WAS FOUND FILLING UP THE GAPS BETWEEN THE BRAIDED NYLON YARN. THE CRYSTAL APPEARED TO RESTRICT THE INFLATION LUMEN. NO VISIBLE DAMAGE OR INCONSISTENCY WAS FOUND FROM THE CATHETER BODY. THE UNKNOWN CRYSTAL WAS SENT FOR CHEMISTRY ANALYSIS. EDS ANALYSIS DETECTED THE FOLLOWING ELEMENTS PRESENT IN THE UNKNOWN MATERIAL FROM GLASS SLIDES: SILICON, SODIUM, MAGNESIUM, CHLORIDE, PHOSPHORUS, ZINC, POTASSIUM, CALCIUM, SULFUR, BROMIDE, AND IRON. EDS ANALYSIS DETECTED THE FOLLOWING ELEMENTS PRESENT ON THE BALLOON INFLATION PORT: SILICON, MAGNESIUM, SODIUM, PHOSPHORUS, SULFUR, CHLORIDE, POTASSIUM AND CALCIUM. THE CUSTOMER REPORT OF "WOULD NOT INFLATE" WAS NOT CONFIRMED ON EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. AS WITH ALL CATHETERIZATION PROCEDURES, COMPLICATIONS MAY OCCUR. PERFORATION, ARTERIOVENOUS FISTULA FORMATION, VENOUS THROMBOSIS, CATHETER TIP SEPARATION, RHYTHM DISTURBANCES, INFECTION, DAMAGE OF THE ATRIOVENTRICULAR VALVES, BALLOON FRAGMENT EMBOLIZATION, AND FAILURE OF BALLOON DEFLATION HAVE ALL BEEN REPORTED INCIDENT TO THE USE OF ATRIOSEPTOSTOMY CATHETERS. IT IS COMMON CLINICAL PRACTICE TO INSPECT THE CATHETER AND BALLOON PRIOR TO USE ON A PATIENT. A BALLOON THAT DOES NOT INFLATE OR DEFLATE WOULD BE DISCOVERED UPON INSPECTION AND THE CATHETER CAN BE EXCHANGED WITH A MINIMAL DELAY IN TREATMENT. THE IFU STATES, ?CARE MUST BE EXERCISED TO AVOID DAMAGE TO THE BALLOON DURING INSERTION OF THE CATHETER?. IF THE BALLOON DEFLATION DIFFICULTY IS NOT DISCOVERED PRIOR TO USE, BLOOD FLOW COULD BE COMPROMISED BETWEEN THE HEART CHAMBERS. 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 ON A FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER WOULD NOT INFLATE. IT IS UNKNOWN IF THE ISSUE OCCURRED PRIOR TO OR DURING USE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. NO OTHER DETAILS WERE ABLE TO BE OBTAINED.