JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Report

Report Number: 1820334-2020-00988
Event Type: Injury
Date Received: May 22, 2020
Report Date: July 20, 2022
Manufacturer: COOK INC
Product Code: JOH
PMA / PMN Number: K133597
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE FROM AN UNKNOWN CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY EXPERIENCED FLANGE SEPARATION. THIS EVENT OCCURRED ON AN UNKNOWN DATE IN 2020 AND THE SEPARATION WAS NOTED SHORTLY AFTER INSERTION. IT WAS NOTED THAT THERE WAS MORE DIFFICULTY THAN USUAL PLACING THE DEVICE. THE PATIENT REQUIRED REINTUBATION AND A SECOND TRACHEOSTOMY. COOK BECAME AWARE OF THIS EVENT ON (B)(6) 2020 UPON BEING NOTIFIED BY (B)(6) HOSPITAL. THE PATIENT REPORTEDLY EXPERIENCED NO ADDITIONAL ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED, AND COOK WAS UNABLE TO NARROW DOWN THE POTENTIAL LOT NUMBER THROUGH A SALES SEARCH. IT SHOULD BE NOTED THAT THE AFFECTED COMPONENT IS SUPPLIED TO COOK THROUGH AN EXTERNAL SOURCE. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS RELATED TO THE REPORTED FAILURE MODE: "WARNINGS- ONLY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES SHOULD USE THIS DEVICE. PRECAUTIONS: AN ULTRASOUND EVALUATION OF THE PATIENT¿S NECK PRIOR TO THE PROCEDURE MAY AID IN THE IDENTIFICATION OF ANATOMICAL VARIANCES. THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCES IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES. STANDARD TECHNIQUES FOR PERCUTANEOUS PLACEMENT OF TRACHEOSTOMY TUBES SHOULD BE EMPLOYED. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THIS DEVICE IS SUPPLIED TO COOK AND SUPPLIER CONTROLS ARE CURRENTLY BEING REVIEWED UNDER A SUPPLIER CORRECTION ACTION REQUEST (SCAR). BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF THE PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE FOR FAILURE WAS NOT ESTABLISHED. IT IS POSSIBLE THAT FORCEFUL HANDLING OF THE DEVICE CAUSED THE FRACTURE. THE CUSTOMER DID REPORT THAT MORE FORCE HAD TO BE APPLIED TO PLACE THE TRACHEOSTOMY TUBE, BUT IT IS UNKNOWN WHETHER THIS IS DUE TO TORTUOUS PATIENT ANATOMY, USER TECHNIQUE, OR ANOTHER FACTOR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK 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.

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.

Additional Manufacturer Narrative · 0

CORRECTION: F6, (ANNEX E), H6 (ANNEX E): E2402 - APPROPRIATE TERM / CODE NOT AVAILABLE, UNSTABLE AIRWAY. INVESTIGATION ¿ EVALUATION. IT WAS ORIGINALLY REPORTED TO COOK ON 11MAY2020 BY (B)(6) HOSPITAL THAT THE TRACHEOSTOMY TUBE FROM A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY (UNKNOWN RPN AND LOT#) EXPERIENCED FLANGE SEPARATION. ADDITIONAL INFORMATION WAS PROVIDED TO COOK ON 30JUN2022 IN THE FORM OF A LITERATURE PUBLICATION. ON AN UNKNOWN DATE IN 2020, A 74-YEAR-OLD FEMALE, WHOSE ORTHOTOPIC LIVER TRANSPLANT WAS COMPLICATED BY REJECTION, DEVELOPED RESPIRATORY FAILURE DUE TO DISSEMINATED ASPERGILLOSIS. SHE UNDERWENT A BRONCHOSCOPIC-GUIDED PDT. SEVERAL HOURS LATER, THE FLANGE WAS NOTED TO BE SEPARATED FROM THE CANNULA AND WAS NOT ABLE TO BE RESEATED. THE DECISION WAS MADE TO CONVERT TO OPEN TRACHEOSTOMY FOR PLACEMENT UNDER DIRECT VISUALIZATION TO AVOID ANY FURTHER COMPLICATIONS. THE PATIENT WAS OROTRACHEALLY INTUBATED, TAKEN TO THE OPERATING ROOM, AND UNDERWENT AN UNEVENTFUL OPEN TRACHEOSTOMY. (CITATION: SHNAYDMAN I, BAUM J, BARDA L, ET AL. (JUNE 29, 2022) FLANGE FRACTURE AND DISLOCATION: AN UNUSUAL COMPLICATION OF PERCUTANEOUS TRACHEOSTOMY. CUREUS 14(6): E26426. DOI:10.7759/CUREUS.26426.) A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE CUSTOMER PROVIDED THREE POTENTIAL RPNS OF THE DEVICE (C-PTISY-100-HC-G-PERC6, C-PTISY-100-HC-G-PERC8, AND C-PTIS-100-HC-G-PERC8). A PHOTO WAS PROVIDED SHOWING A PERC8 SHILEY, AND NO SALES WERE OF C-PTIS-100-HC-G-PERC8 WERE NOTED TO THE USER FACILITY, SO THE DEVICE MASTER RECORD OF C-PTISY-100-HC-G-PERC8 WAS REVIEWED. COOK CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. POTENTIAL NONCONFORMANCES FROM THE DEVICE¿S LOT COULD NOT BE CONFIRMED DUE TO AN UNKNOWN LOT NUMBER. A DATABASE SEARCH FOR OTHER COMPLAINTS FROM THE DEVICE¿S LOT COULD NOT BE PERFORMED FOR SIMILAR REASONS. SINCE POTENTIAL NONCONFORMANCES OR OTHER COMPLAINTS FROM THE DEVICE¿S LOT COULD NOT BE CONFIRMED, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THIS INFORMATION, COOK COULD NOT CONFIRM THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. 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: WARNINGS: ¿ ONLY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES SHOULD USE THIS DEVICE. PRECAUTIONS: ¿ BRONCHOSCOPIC GUIDANCE IS STRONGLY RECOMMENDED DURING PLACEMENT OF THIS DEVICE TO REDUCE LIKELIHOOD OF PARATRACHEAL INSERTION AND TO DETERMINE THE INTRATRACHEAL POSITION OF THE NEEDLE, WIRE GUIDE, DILATORS AND TRACHEOSTOMY TUBE. ¿ THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCES IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES. STANDARD TECHNIQUES FOR PERCUTANEOUS PLACEMENT OF TRACHEOSTOMY TUBES SHOULD BE EMPLOYED. HOW SUPPLIED : UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT A DEFINITIVE CONCLUSION COULD NOT BE MADE. IT IS POSSIBLE THAT FORCEFUL HANDLING OF THE DEVICE CAUSED THE DEVICE TO FRACTURE. THE CUSTOMER DID REPORT THAT MORE FORCE HAD TO BE APPLIED TO PLACE THE TRACHEOSTOMY TUBE, BUT IT IS UNKNOWN WHETHER THIS IS DUE TO TORTUOUS PATIENT ANATOMY, USER TECHNIQUE, OR ANOTHER FACTOR. SCAR-2020-032 WAS PREVIOUSLY OPENED REGARDING THIS ISSUE AND ALSO COULD NOT DETERMINE A ROOT CAUSE OF FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. LITERATURE CITATION: SHNAYDMAN I, BAUM J, BARDA L, ET AL. (JUNE 29, 2022) FLANGE FRACTURE AND DISLOCATION: AN UNUSUAL COMPLICATION OF PERCUTANEOUS TRACHEOSTOMY. CUREUS 14(6): E26426. DOI:10.7759/CUREUS.26426. ADDITIONAL INFORMATION: A2, A3, B3, B5, B7, D4, G2, H6 (ANNEX E, ANNEX F, ANNEX A, ANNEX G, ANNEX B, ANNEX C, ANNEX D) B3: UNSPECIFIC DATE IN 2020 D4: INFORMATION PROVIDED INDICATES THERE ARE THREE POSSIBLE RPN'S: C-PTISY-100-HC-G-PERC6, C-PTISY-100-HC-G-PERC8, C-PTIS-100-HC-G-PERC8 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.

Additional Manufacturer Narrative · 0

B3- DATE OF EVENT: 2020. 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.