FDA Adverse Event Malfunction Summary report: N

FIBEROPTIX

MDR report key: 18777380 · Received February 26, 2024

Report

Report Number
18777380
Event Type
Malfunction
Date Received
February 26, 2024
Date of Event
September 29, 2023
Report Date
October 5, 2023
Manufacturer
TELEFLEX INCORPORATED
Product Code
DSP
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PER DOCTOR¿S NOTES: PATIENT WAS TAKEN EMERGENTLY TO CARDIAC CATHETERIZATION LAB (CCL) AFTER PRESENTING IN THE EMERGENCY DEPARTMENT (ED) WITH BLOOD PRESSURE (BP) 173/107, TROPONIN 1.095 AND ELECTROCARDIOGRAM (EKG) SHOWING ST ELEVATION INVOLVING LEADS I, AVL, V1 AND V2. IN CCL, PATIENT RECEIVED LEFT ANTERIOR DESCENDING (LAD) STENT PLACEMENT, BUT THE LEFT DIAGONAL COULD NOT BE OPENED. DURING CARDIAC CATHETERIZATION, THERE WAS CONCERN FOR LEFT MAIN DISEASE; IABP WAS PLACED. HE WAS THEN TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR FURTHER CARE. AROUND 4AM, BLOOD WAS SEEN IN TUBE OF INTER-AORTIC BALLOON PUMP (IABP), RUPTURE OF IABP OCCURRED. CARDIOLOGY WAS CALLED AND IABP WAS REMOVED. PATIENT COMPLAINED OF MODERATE PAIN IN RIGHT FEMORAL ARTERIAL SITE WHERE IABP WAS PLACED, OTHERWISE IS WELL. PER REPORT BY REGISTERED NURSE (RN): IABP BALLOON HAD LEAKED AND WAS REMOVED FROM THE RIGHT GROIN AROUND 04:15. IABP WAS REMOVED BY DOCTOR. MANUAL PRESSURE WAS HELD AND THE C-CLAMP WAS PLACED FOR 2 HOURS. ALL DOCTORS AWARE. VITAL SIGNS WERE STABLE AND THE PATIENT HAS NOT HAD ANY CHEST PAIN. LATER ON THAT SAME DAY, PATIENT UNDERWENT THE FOLLOWING PROCEDURES: REPAIR OF FEMORAL ARTERY PSEUDOANEURYSM CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) X4 WITH INTRA-OP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND PLACEMENT OF SWAN-GANZ CATHETER ON RIGHT INTERNAL JUGULAR VEIN. MANUFACTURER RESPONSE FOR INTRA AORTIC BALLOON PUMP, IABP FIBEROPTIX (PER SITE REPORTER). DEVICE WAS GIVEN TO CCL MANAGER (BY OBSERVATIONAL CARE UNIT (OCU) DIRECTOR) WHO IN TURN GAVE IT TO FIELD REPRESENTATIVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1972199 FIBEROPTIX SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP TELEFLEX INCORPORATED 18F21L0024

Patients

Seq Age Sex Outcome Treatment
1 81 YR Female Other