FDA Adverse Event Injury Summary report: N

MERIT MEDICAL DURA MAX 28 CM TUNNELED HEMODIALYSIS CATHETER

MDR report key: 21397808 · Received February 18, 2025

Report

Report Number
MW5166325
Event Type
Injury
Date Received
February 18, 2025
Date of Event
December 24, 2024
Report Date
February 11, 2025
Manufacturer
MERIT MEDICAL SYSTEMS, INC.
Product Code
MSD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
003
Health Professional
N

Narratives

Description of Event or Problem · 0

WHILE PLACING A TUNNELED HEMODIALYSIS CATHETER, THE TEAR AWAY PORTION MALFUNCTIONED AND PHYSICIAN HAD TO PULL THE CATHETER OUT, RESULTING IN A SUSPECTED AIR EMBOLUS. A RAPID RESPONSE WAS CALLED BECAUSE THE PATIENT SUBSEQUENTLY STARTED TO HAVE OXYGEN DESATURATIONS. THE PATIENT ULTIMATELY WAS TRANSFERRED BACK TO ICU AND REQUIRED INTUBATION DUE TO A COMPROMISED AIRWAY FROM ATTEMPTS AT PLACING A NASAL TRUMPET TO ASSIST IN BAG VALVE MASK RESPIRATIONS. PT IS A 55 YEAR OLD MALE ADMITTED ON 12/16 S/P (STATUS POST) SEPSIS D/T PNA (PNEUMONIA). HX (HISTORY): STROKE, PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE, NON-AMBULATORY, HTN (HYPERTENSION), HIV ( HUMAN IMMUNODEFICIENCY VIRUS), GERD (GASTROESOPHAGEAL REFLUX DISEASE), SEIZURE, ETOH ABUSE, NEUROSYPHILIS, STAGE 2 SACRAL PRESSURE WOUND, CONTRACTURES. DEVICE FAILURE REPORTED TO THE MANUFACTURER AND REPORT TO BE SUBMITTED WITH THE FDA. 12/24 0925 - PT TO IR FOR TUNNELED HEMODIALYSIS CATHETER PLACEMENT. PER IR NOTE: "PATIENT HAD DESATURATIONS IMMEDIATELY AFTER PLACEMENT OF TUNNELED HD CATHETER. RAPID RESPONSE TEAM PROMPTLY CALLED, PATIENT PLACED IN LLD POSITION OF POSITIVE PRESSURE/SUPPLEMENT O2 GIVEN, EVENTUALLY SATURATIONS IMPROVED TO 90S ON NON REBREATHER. PATIENT SENT BACK TO ICU FOLLOWING THIS. SUSPECT COMPONENT OF AIR EMBOLISM VERSUS OBSTRUCTIVE AIRWAY OR COMBINATION OF BOTH." BACK TO MSICU ON 100% NONREBREATHER MASK. HE REQUIRED NASAL TRUMPET IN THE RIGHT NARE DURING THE PROCEDURE CAUSING EPISTAXIS. CXR = DIFFUSE BILATERAL AIRSPACE DISEASE. 1115 - CODE BLUE CALLED, "CODE BLUE CALLED AND DR. (B)(6) AND DR. (B)(6) RESPONDED PROMPTLY. ACLS PROTOCOL UNDERWAY UPON ARRIVAL. CRITICAL CARE IN THE ROOM PERFORMING BRONCHOSCOPY WITH CONCERN FOR UPPER AIRWAY OBSTRUCTION. PEA (PULSELESS ELECTRICAL ACTIVITY) ARREST. PATIENT WAS GIVEN EPINEPHRINE X3, SODIUM BICARBONATE X1, CALCIUM CHLORIDE GIVEN X1, ROSC (RETURN OF SPONTANEOUS CIRCULATION ) ACHIEVED. PLEASE SEE CODE BLUE SHEET FOR DETAILS. CHAPLAIN PRESENT." 1216 BRONCH = EXAMINATION OF THE AIRWAYS REVEALED NORMAL AIRWAYS. THERE WAS NO ENDOBRONCHIAL NODULARITY OR MASSES. THERE WAS NO ACTIVE BLEEDING NOTED 12/25 - OVERNIGHT HE BEGAN DEVELOPING FACIAL TWITCHING. HE STILL HAS SOME SLOW BLEEDING FROM HIS ORAL CAVITY REQUIRING SUCTIONING. REMAINS ON FULL VENT SUPPORT. OFF PRESSORS. ABG PH 7.49 PCO2 33 PO2 198 HCO3 24.8. ON CRRT. LOWER RESP CULTURES WITH NORMAL RESPIRATORY FLORA, FEW GRAM-NEGATIVE BACILLI. 12/28 - CXR (CHEST X-RAY) DEMONSTRATES IMPROVING BILATERAL INTERSTITIAL AND ALVEOLAR BILATERAL INFILTRATES. EEG YESTERDAY DEMONSTRATED RECURRENT FOCAL LEFT HEMISPHERIC MOTOR SEIZURES AND DIFFUSE CEREBRAL DYSFUNCTION. NEUROLOGY WAS CONSULTED, NOW ON CONTINUOUS EEG, ON PHENOBARBITAL. HGB 6.1, 1 UNIT PRBC TRANSFUSED 12/29 - HGB 8.6, NA 128 (132), CR 2.71 (1.67). NURSING REPORTS THAT WITH WEANING OF PROPOFOL, THE PATIENT APPEARS TO DEVELOP TWITCHING AND REPETITIVE MOVEMENTS OF HIS FACIAL MUSCLES. RESPIRATORY CULTURES GROWING ACINETOBACTER BAUMANN I AND PSEUDOMONAS. EEG WITH RECURRENT FOCAL LEFT HEMISPHERIC MOTOR SEIZURES AND DIFFUSE CEREBRAL DYSFUNCTION. 12/30 - HGB 6.8, PRBC ORDERED. PLT 105, NA 127. DIC (DISSEMINATED INTRAVASCULAR COAGULATION) PANEL ORDERED. NEURO IR PACKED PT NOSE, NO FURTHER BLEEDING NOTED. 12/31 - PT REMAINS INTUBATED ON VENT SUPPORT WITH CONTINUED SEIZURE ACTIVITY & REQUIRING BLOOD TRANSFUSIONS EVERY OTHER DAY. FAMILY DECIDED TO PURSUE CMO. TOD 1134.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
42682 MERIT MEDICAL DURA MAX 28 CM TUNNELED HEMODIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD MERIT MEDICAL SYSTEMS, INC. I3072554

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention