BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
Report
- Report Number
- 1820334-2024-00019
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- December 14, 2023
- Report Date
- June 3, 2024
- Manufacturer
- COOK INC
- Product Code
- JOH
- UDI-DI
- 00827002576865
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - CUSTOMER (PERSON): STREET: (B)(6). G4 ¿ PMA/510(K) #: K193133. 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, UNAVAILABLE, OR UNCHANGED. CORRECTION: B5 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT THE BLUE RHINO DILATOR OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE BLUE RHINO HAD TO BE REPOSITIONED AT THE SAFETY LEVEL TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, THE CUSTOMER DID PROVIDE A PHOTO SHOWING THE DEVICE HAD ADVANCED OVER THE SAFETY RIDGE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT AND RELATED SUB-ASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH OF THE COMPLAINT LOT IDENTIFIED ONE OTHER EVENT REPORTED FOR AN UNRELATED FAILURE MODE. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_PTISGI_REV0] ¿BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER", SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: "CONTRAINDICATIONS PATIENTS WITH ENLARGED THYROIDS NONPALPABLE CRICOID CARTILAGE PREVIOUS SURGERY AT THE TRACHEOSTOMY SITE (E.G. THYROIDECTOMY) POTENTIAL ADVERSE EVENTS PERFORATION OF THE TRACHEA FAILED TRACHEOSTOMY TUBE PLACEMENT HYPOXIA INSTRUCTIONS FOR USE TRACHEOSTOMY PROCEDURE 1. PALPATE THE LANDMARK STRUCTURES (THYROID NOTCH, CRICOID CARTILAGE) TO ASCERTAIN PROPER LOCATION FOR TRACHEOSTOMY TUBE PLACEMENT. ACCESS AND ULTIMATELY TUBE PLACEMENT IS IDEALLY MADE AT THE LEVEL BETWEEN THE FIRST AND SECOND TRACHEAL CARTILAGES OR BETWEEN THE SECOND D THIRD TRACHEAL CARTILAGES WHENEVER FEASIBLE. 2. ¿ MAKE A 1.5-2.0 CM SKIN INCISION (VERTICAL OR HORIZONTAL) AT THE CHOSEN INSERTION SITE ¿ NOTE: AN ADEQUATE SKIN INCISION AND BLUNT DISSECTION OF THE SUBCUTANEOUS TISSUE CAN MINIMIZE THE NEED FOR EXCESSIVE FORCE¿ 13. ACTIVATE THE HYDROPHILIC COATING BY IMMERSING THE DISTAL END OF THE BLUE RHINO G2-MULTI DILATOR IN STERILE WATER OR SALINE. 14. ADVANCE THE BLUE RHINO G2-MULTI DILATOR AND THE GUIDING CATHETER AS A UNIT OVER THE WIRE GUIDE, WHILE MAINTAINING WIRE GUIDE POSITION. NOTE: ALIGN THE PROXIMAL END OF THE GUIDING CATHETER AT THE MARK ON THE PROXIMAL PORTION OF THE WIRE GUIDE. THIS WILL ENSURE THAT THE DISTAL END OF THE GUIDING CATHETER IS PROPERLY POSITIONED BACK ON THE WIRE GUIDE, PREVENTING POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING SUBSEQUENT MANIPULATIONS. NOTE: BRONCHOSCOPIC GUIDANCE MAY ALSO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL. 15. BEGIN TO DILATE THE TRACHEAL ACCESS SITE BY ADVANCING THE GUIDING CATHETER AND BLUE RHINO G2-MULTI DILATOR INTO THE TRACHEA. TO PROPERLY ALIGN THE DILATOR ON THE WIRE GUIDE/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 ON THE GUIDING CATHETER TO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING INTRODUCTION. 16. ADVANCE AND PULL BACK THE DILATING ASSEMBLY SEVERAL TIMES TO EFFECTIVELY DILATE THE TRACHEAL ACCESS SITE. NOTE: THE WIRE GUIDE MUST ALWAYS LEAD THE DILATORY AND THE GUIDING CATHETER ASSEMBLY TO PREVENT POSSIBLE TRAUMA TO THE POSTERIOR TRACHEAL WALL DURING DILATION. CARE SHOULD BE TAKEN TO KEEP THE GUIDING CATHETER ASSEMBLY PROPERLY ALIGNED WITH THE MARK ON THE PROXIMAL PORTION OF THE WIRE GUIDE. THIS WILL ENSURE THAT THE TIP OF THE GUIDING CATHETER ASSEMBLY DOES NOT ADVANCE BEYOND THE DISTAL TIP OF THE WIRE GUIDE WITHIN THE TRACHEA¿¿ BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE EVENT. THE BLUE RHINO AND GUIDING CATHETER ARE MADE OF FLEXIBLE MATERIAL. THE BLUE RHINO CAN BE FORCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER, BUT COOK CANNOT CONFIRM THAT EXCESSIVE FORCE WAS USED. 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.
IT WAS REPORTED THAT THE BLUE RHINO DILATOR OF A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE DEVICE WAS REQUIRED FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE PLACED IN THE SECOND TRACHEAL SPACE. DURING THE PROCEDURE, THE 14 FRENCH PUNCH DILATOR BENT WHICH CAUSED THE WIRE GUIDE TO KINK. A COMPETITOR'S 14FR DILATOR WAS USED TO CONTINUE THE PROCEDURE. THEN DURING DILATION, THE BLUE RHINO ADVANCED OVER THE SAFETY RIDGE OF THE GUIDING CATHETER. THE BLUE RHINO WAS REPOSITIONED AT THE SAFETY LEVEL, AND THE PROCEDURE WAS COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
IMAGING GUIDANCE WAS USED DURING PLACEMENT OF THE DEVICE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647466 | BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET | JOH TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | COOK INC | N/A | 15550985 | 00827002576865 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |