FDA.reportPublic FDA data

MAUDE MDR 7938460

MDR report key
7938460
Report number
1035166-2018-00090
Event key
0
Event type
3
Date of event
2018-08-13
Date received
2018-10-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DOUG MYERS
Address
3816 DE SOTO BLVD. PALM HARBOR FL 34683 US
Phone
727-727-7279
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATAR D-A, DARK BLUE DISPOSABLECABLE, ELECTRODEOSCOR INC.IKDATAR D-AATAR D-AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-050

Event Narratives#

N

Patient 1

THE DEVICE WAS IN USE FOR TREATMENT. THE USER NOTED THAT THE PATIENT DEATH IS RELATED TO A PATIENT CONDITION. THE PACER HAD NOTHING TO DO WITH IT. THE DEVICE WAS NOT RETURNED AND THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD OR COMPLAINT HISTORY COULD NOT BE PERFORMED. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. PER QUALITY ASSURANCE ATAR CABLE IN PROCESS AND FINAL INSPECTION PROCEDURE: IN PROCESS INSPECTION, INSPECT 100% FOR CONTINUITY. A) CONNECT BLACK SHROUDED PIN AND BLACK PIN RECEPTACLE TO THE MULTIMETER AND VERIFY CONTINUITY IS PRESENT. THE READING SHALL BE LESS THAN 2.0 OHMS. THE MULTIMETER DISPLAY SHOULD BE STEADY, NOT ERRATIC. B) REPEAT THE SAME FOR THE RED SHROUDED PIN AND RED PIN RECEPTACLE. IN FINAL INSPECTION, INSPECT 100% FOR CONTINUITY. A) CONNECT BLACK SHROUDED PIN AND BLACK PIN RECEPTACLE TO THE MULTIMETER AND VERIFY CONTINUITY IS PRESENT. THE READING SHALL BE LESS THAN 2.0 OHMS. THE MULTIMETER DISPLAY SHOULD BE STEADY, NOT ERRATIC. B) REPEAT THE SAME FOR THE RED SHROUDED PIN AND RED PIN RECEPTACLE. PER INSTRUCTIONS FOR USE (IFU) IT CAUTIONS THE USER: PRIOR TO USE, READ ALL PACKAGE INSERTS, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN SEVERE PATIENT INJURY OR DEATH. DO NOT CONNECT ANY CABLE MODEL TO A/C POWER SOURCE; CONNECTION OF EXPOSED PINS TO A/C POWER SOURCE MAY POSE A RISK OF SERIOUS INJURY OR DEATH. EXTENSION CABLES ARE NOT INTENDED FOR USE WITH APNEA MONITORS. THE DIRECTIONS FOR USE STATE: FIRST ATTACH THE PROXIMAL CONNECTOR(S) TO A PACEMAKER/ANALYZER OR ANOTHER EXTENSION CABLE WHILE OBSERVING POLARITY INDICATED BY THE COLOR. THEN ATTACH THE DISTAL CONNECTOR(S) TO THE TEMPORARY LEAD CONNECTOR OR TO ANOTHER EXTENSION CABLE, AGAIN OBSERVING POLARITY BY THE COLOR. THE DETACHMENT OF THE CONNECTION SHOULD BE DONE IN THE REVERSE ORDER.

D

Patient 1

IT WAS REPORTED THE HOSPITAL WAS HAVING ISSUES WITH OUR ATAR CABLES NOT STAYING CONNECTED TO THEIR TRANSVENOUS PACING LEADS AND MYOCARDIAL PACING WIRES. THEY ARE HAVING TROUBLE WITH LEADS PULLING OUT FROM THE DISTAL END OF THE ATAR CABLES AFTER THE RECEPTACLE CONNECTOR IS TIGHTENED DOWN. THEY STATED THAT IT HAS HAPPENED SEVERAL TIMES AND SOMETIMES IN EMERGENCY SITUATIONS WHERE THE NURSING STAFF HAVE GLOVES ON AND POSSIBLY BLOOD WHICH MAY AFFECT THEIR ABILITY TO TIGHTEN DOWN THE CONNECTOR. THEY SAID THEY HAVE HAD MULTIPLE ISSUES WHERE THEY LOST CAPTURE/PACING SEVERAL TIMES IN CRITICAL PATIENTS DUE TO CONNECTION ISSUES. THE REPORTER WAS NOT ABLE TO GET THE BRAND/MODELS OF THE TEMPORARY TRANSVENOUS PACING LEADS (CATH LAB) OR THE TEMPORARY PACING WIRES (CVOR) CURRENTLY USED BY THE HOSPITAL. PER THE HOSPITAL, THE DEVICE MODEL NUMBER IS ATAR D-A. ON 13-SEP-2018 ADDITIONAL INFORMATION WAS RECEIVED THE PATIENT HAD EXPIRED ON (B)(6) 2018. DURING CATH PROCEDURE PATIENT CODED. IT WAS RELATED TO PATIENT CONDITION; THE PACER HAD NOTHING TO DO WITH IT. THE HOSPITAL DOES NOT HAVE THE LOT NUMBER, AND THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THEY REPORTED THIS IS NOT A ONE-TIME INCIDENT. IT'S NOT THE WIRE PULLING OUT. THE NURSING STAFF HAVE GLOVES ON AND POSSIBLY BLOOD WHICH MAY AFFECT THEIR ABILITY TO TIGHTEN DOWN THE CONNECTOR.