FDA Adverse Event Injury Summary report: N

TRUFREEZE CRYOSPRAY SYSTEM

MDR report key: 5617028 · Received April 28, 2016

Report

Report Number
3010140265-2016-00002
Event Type
Injury
Date Received
April 28, 2016
Date of Event
April 1, 2016
Report Date
April 26, 2016
Manufacturer
CSA MEDICAL, INC.
Product Code
GEH
PMA / PMN Number
K160273
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT IS (B)(6) FEMALE WITH A HISTORY OF (B)(6) WITH KNOWN EXTENSIVE SCARRING AS A RESULT OF THIS INFECTION. SHE WAS LEFT WITH SIGNIFICANT STENOSIS IN LEFT MAIN STEM BRONCHUS (LMB) AND DISTALLY AS WELL. SHE ALSO HAS AT LEAST TWO AREAS OF SIGNIFICANT TRACHEAL STENOSIS. HER PRIOR HISTORY REVEAL A VATS PROCEDURE ON THE LEFT AS WELL FOR A MASS (STATUS OF PATHOLOGY NOT STATED). SHE HAD PRESENTED 4 TO 5 TIMES PRIOR FOR SPRAY CRYOTHERAPY AND DILATION OF HER AREAS OF STENOSIS AND HAS UNDERGONE MULTIPLE PROCEDURES FOR SYMPTOMATIC SHORTNESS OF BREATH WITH HER CURRENT PHYSICIAN AND WITH OTHER PHYSICIANS IN THE PAST. HER INITIAL TRACHEAL STENOSIS HAS BEEN AS NARROW AS 4 MM IN DIAMETER WHICH REQUIRED TRACHEOSTOMY IN THE PAST. HER MOST RECENT SPRAY CRYOTHERAPY TREATMENT WAS ABOUT 4-5 WEEKS PRIOR TO THE CURRENT TREATMENT. ADDITIONALLY SHE HAS DEVELOPED ASPERGILLOSIS POST HER (B)(6) INFECTION, HAS HAD SEVERAL STENTS PLACED INCLUDING TRACHEAL AND LMB. WITH HER ASPERGILLOSIS AND STENTS, SHE IS NOT A CANDIDATE FOR TRACHEAL RESECTION OF HER STENOSIS. SHE PRESENTED AGAIN JUST BEFORE THIS TREATMENT SESSION WITH WORSENING SYMPTOMS. ON THE DAY OF HER COMPLICATION A RIGID SCOPE WAS USED WITH A 12 MM OUTER/10 MM INNER DIAMETER. THE RIGID SCOPE COULD NOT PASS DEEPLY INTO THE TRACHEA DUE TO THE PRESENCE OF HER TRACHEAL STENT AND DISTAL TRACHEAL STENOSIS. FURTHER IT WAS FOUND THAT THE LEFT MAIN STEM STENT HAD TAPERED AT THE END TO 4 MM DIAMETER OPENING. THE DECISION WAS MADE TO USE SPRAY CRYOTHERAPY TO ABLATE THE SCAR TISSUE AT THE DISTAL END OF THE STENT. A DESIGNATED MEDICAL PROVIDER WAS ASSIGNED TO MONITOR THE CHEST AND STOMACH FOR ANY DISTENTION DURING THE SPRAY PROCEDURE. THE DOCTOR CHOSE TO PRE-SPRAY OUTSIDE BODY TO COOL THE SCOPE/CATHETER IN AN ATTEMPT TO DECREASE THE TIME TO DELIVERY OF LIQUID NITROGEN. NO VISIBLE GAS EGRESS AFTER 5 SECOND SPRAY ON THE NORMAL FLOW SETTING WAS NOTED DURING TREATMENT OF THE DISTAL LMG. THE OBSERVING MEDICAL PROVIDER MENTIONED SHE "MAY" HAVE FELT A SLIGHT RISE IN THE CHEST/STOMACH. ALTHOUGH THE PATIENT WAS INITIALLY STABLE, THE TREATING PHYSICIAN USED FLUOROSCOPY TO EXAMINE FOR PNEUMOTHORAX. NO INITIAL SIGN OF PNEUMOTHORAX ON THE CRYO SIDE BUT THERE IS EXTENSIVE SCARRING ON THE LEFT. PNEUMOTHORAX WAS DETECTED ON OPPOSITE SIDE OF TREATMENT. A RIGHT CHEST TUBE WAS PLACED AND INITIALLY THE PATIENT RESPONDED WELL. DURING THE TIME OF POST SPRAY CRYO AND THROUGH THE ASSESSMENT THE PATIENT WAS MAINTAINED ON POSITIVE PRESSURE JET VENTILATION. PHYSICIAN PROCEEDED TO DILATE THE LEFT MAIN STEM AND PATIENT THEN DECOMPENSATED AGAIN. A CHEST TUBE WAS PLACED ON THE LEFT AND PATIENT WAS STABILIZED. SHE REQUIRED EXTENSIVE SUPPORT DURING THE STABILIZATION AND WAS TAKEN TO INTENSIVE CARE. A PNEUMOPERITONEUM, RESULTING FROM EXTENSION OF HER PNEUMOMEDIASTINUM WAS NOTED. THIS FINDING DID NOT REQUIRE ANY INTERVENTION. THE PATIENT WAS IN THE ICU FOR FIVE DAYS AND THEN DISCHARGED HOME. ON FOLLOW UP CHEST X-RAY SHE WAS NOTED TO HAVE AIR/FLUID LEVELS IN THE PARTS OF THE LEFT LUNG THAT HAVE NO DIRECT CENTRAL AIRWAY ACCESS BUT DO HAVE AIR MOVEMENT INTO THE AREA DUE TO COLLATERAL VENTILATION. THESE AREAS WERE NOT APPROACHED AND SIMPLY WATCHED. AT SEVERAL WEEKS POST EVENT, THESE AREAS ARE RETRACTING. THEY MOST LIKELY REPRESENT FLUID/GAS IN THESE SPACES AND INVOLVEMENT WITH ASPERGILLOSIS CANNOT BE RULED OUT. THE PATIENT HAS RETURNED TO HER NORMAL STATE AND WILL REQUIRE FURTHER PULMONARY INTERVENTIONS AND AIRWAY DILATION IN THE NEAR FUTURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
271023 TRUFREEZE CRYOSPRAY SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL, INC. CC3-01

Patients

Seq Age Sex Outcome Treatment
1 56 YR Hospitalization| R