FDA.reportPublic FDA data

MAUDE MDR 8198130

MDR report key
8198130
Report number
0002090040-2018-00018
Event key
0
Event type
3
Date of event
2018-11-14
Date received
2018-12-26
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
MR. MARISSA RICHMOND
Address
1810 W. DRAKE DRIVE TEMPE AZ 85283 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NACATHETER, RECORDING, ELECTRODE, REPROCESSEDSTRYKER SUSTAINABILITY SOLUTIONS PHOENIXNLH401582401582RR3515632N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-260

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED. AS THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS, EVALUATION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR FOR THE REPORTED LOT NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: USER IMPROPERLY MANIPULATES CATHETER AND/OR GUIDING SHEATH. ELECTRODE DAMAGE CAUSED BY MISHANDLING/IMPROPER STORAGE. POOR FIT OF COMPONENTS OR COMPONENT DAMAGE CAUSES USER TO EXERT EXCESSIVE FORCE INSERTING DEVICE (E.G. KINKS, BENDS, ELECTRODE DAMAGE, CUTS). THE INSTRUCTIONS FOR USE (IFU) STATE: INSPECT THE CATHETER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE CATHETER IF ELECTRODES APPEAR LOOSE OR IF ANY DAMAGE IS NOTED. IF SUCH PROBLEMS EXIST, RETURN THE CATHETER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. CONNECT THE CATHETER TO THE CORRESPONDING CABLE CONNECTOR. CONNECT THE CABLE TO THE CORRECT ELECTRONIC EQUIPMENT FOR RECORDING AND/OR SENSING. OBSERVE POLARITY OF PROXIMALLY LOCATED CONNECTOR PINS OF THE INTERFACE CABLE WHEN CONNECTING TO THE ELECTRONIC EQUIPMENT. ISOLATE ANY UNUSED CONNECTOR PINS TO REDUCE DEVELOPMENT OF ACCIDENTAL CURRENT PATHWAYS TO THE HEART. FOLLOW A SUITABLE ELECTROPHYSIOLOGY STUDY PROTOCOL. DO NOT AUTOCLAVE CATHETER. DO NOT USE FOR ELECTRICAL ABLATION. AVOID EXCESSIVE CONTACT OF HANDPIECE WITH FLUIDS, AS THIS COULD ADVERSELY AFFECT THE ELECTRICAL PERFORMANCE OF THE CATHETER. DIAGNOSTIC EP CATHETERS ARE NOT RECOMMENDED FOR LONG TERM PACING. INSPECT THE PACKAGING AND CATHETER FOR DAMAGE OR DEFECTS PRIOR TO USE. THE REPORTED EVENT WILL BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

D

Patient 1

IT WAS REPORTED THAT DURING AN ABLATION FOR ATRIAL FIBRILLATION, THE DOCTOR OBSERVED A DROP IN THE PATIENT'S BLOOD PRESSURE. AFTER CHECKING ON INTRACARDIAC ECHO, THE DOCTOR NOTED A SMALL PERICARDIAL EFFUSION. HE STATED THAT HE BELIEVED THE EFFUSION WAS DUE TO A PERFORATION IN THE CORONARY SINUS WHEN HE HAD PLACED A CATHETER THERE EARLIER IN THE CASE (STRYKER LIVEWIRE). THE PHYSICIAN PROCEEDED WITH THE CASE AND COMPLETED THE PROCEDURE, LEAVING THE CORONARY SINUS CATHETER IN PLACE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.