1820334-2021-00885
Report
- Report Number
- 1820334-2021-00885
- Event Type
- Injury
- Date Received
- March 4, 2021
- Report Date
- February 14, 2022
- Manufacturer
- COOK INC
- Product Code
- KCG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION- THE SUMMARY REPORT DESIGNATION IS INCORRECT; THE REPORT IS NOT A SUMMARY REPORT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. AN ISSUE WAS REPORTED WITH AN UNKNOWN BLUE RHINO TRACHEOSTOMY SET FROM AN UNKNOWN LOT. AT AN UNKNOWN POINT DURING THE PROCEDURE, THE BLUE RHINO DILATOR ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER, DAMAGING THE TRACHEA. COOK BECAME AWARE OF THIS EVENT UPON BEING NOTIFIED BY MULTICARE MEDICAL CENTER. THE PATIENT REQUIRED AN OPEN TRACHEOSTOMY AND INTUBATION PAST THE TRACHEAL INJURY AS A RESULT OF THIS INCIDENT. PATIENT PRE-EXISTING CONDITIONS INCLUDED VIRAL ENCEPHALOPATHY WITH PROLONGED COMA. PATIENT OUTCOME WAS DESCRIBED AS GUARDED. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO THE LACK OF LOT INFORMATION FROM THE FACILITY. REVIEW OF THE SALES RECORDS TO THE USER FACILITY OVER THREE YEARS PRIOR TO THE DATE COOK WAS INFORMED COULD NOT SUFFICIENTLY NARROW DOWN THE LOT NUMBER. THE PRODUCT¿S DESIGN HISTORY FILE (DHF) SHOWED THAT RISK CONTROLS ARE IN PLACE TO MITIGATE THIS FAILURE. COOK ALSO REVIEWED PRODUCT LABELING FOR THE ASSUMED RPN. INSTRUCTIONS FOR USE (IFU) DOCUMENT C_T_PTIS_REV8 [CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER] IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: TRACHEOSTOMY PROCEDURE 15. BEGIN TO DILATE THE TRACHEAL ACCESS SITE BY ADVANCING THE GUIDING CATHETER AND CIAGLIA BLUE RHINO DILATOR INTO THE TRACHEA. TO PROPERLY ALIGN THE DILATOR ON THE WIRE/GUIDING CATHETER ASSEMBLY, POSITION THE PROXIMAL END OF THE DILATOR AT THE SINGLE POSITIONING MARK ON THE GUIDING CATHETER. THIS WILL ENSURE THAT THE DISTAL TIP OF THE DILATOR IS PROPERLY POSITIONED AT THE SAFETY RIDGE OF THE GUIDING CATHETER TO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING INTRODUCTION. HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU, AND DHF SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS USED WHEN MANIPULATING THE DEVICE, PUSHING THE DILATOR PAST THE SAFETY RIDGE, BUT THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCY CONTRIBUTED TO THE EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: A2, A4, B5, B7, H6- HEALTH EFF CLINICAL CODE GRID, H6- HEALTH EFF IMPACT CODE GRID, H6- MED DEVICE PROBLEM CODE GRID . A2- AGE: 30-40 YEARS-OLD . A4- WEIGHT: APPROXIMATELY 60 KGS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 04MAR2021, IT WAS REPORTED THAT THE PATIENT WAS INTUBATED OROTRACHEALLY PAST THE TRACHEAL INJURY TO COMPLETE THE PROCEDURE AFTER ALL COMPONENTS WERE REMOVED AS THEY REQUIRED A FORMAL OPEN TRACHEOSTOMY. THE WHITE GUIDING CATHETER WAS USED WHEN THE BLUE RHINO DILATOR WAS BEING ADVANCED INTO THE TRACHEA; THE DILATOR WAS ADVANCED PAST THE WHITE RIDGE. PATIENT OUTCOME/CURRENT CONDITION HAS BEEN DESCRIBED AS "GUARDED". NO ADVERSE EFFECTS HAVE BEEN REPORTED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: TRAUMA DIRECTOR. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT DURING A PROCEDURE, A PHYSICIAN ADVANCED AN UNKNOWN CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY DEVICE THROUGH THE POSTERIOR WALL OF THE PATIENT'S TRACHEA. "BRONCH VISUALIZATION" WAS USED. NO DEVICE MALFUNCTION HAS CURRENTLY BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313065 | KCG | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Life Threatening| R |