FROVA INTUBATING INTRODUCER
Report
- Report Number
- 3002808486-2022-01045
- Event Type
- Injury
- Date Received
- December 7, 2022
- Report Date
- February 9, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K) K161813. INVESTIGATION IS STILL IN PROGRESS. 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.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A DIFFICULT ORAL-TRACHEAL INTUBATION A DOUBLE LUMEN ENDOTRACHEAL TUBE AND THE FROVA INTUBATING INTRODUCER WAS USED TO IMPLANT A LEFT-SIDE BRONCHO-CATH. THE ORAL-TRACHEAL INTUBATION WAS SUCCESSFUL AND THE FROVA WAS REMOVED BUT WHEN THE PHYSICIAN CHECKED WITH A FIBROSCOPE A PIECE OF THE FROVA REMAINED ON THE EDGE OF THE PROBE. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. ACCORDING TO THE INSTRUCTIONS FOR USE THE 14.0 FRENCH FROVA INTRODUCER HAS BEEN DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6 MM OR LARGER. FURTHERMORE, THE IFU WARN THAT THE TUBE AND THE INTRODUCER MUST BE LUBRICATED BEFORE USE AND THAT CARE MUST BE TAKEN WHEN INTRODUCING/REMOVING THE INTRODUCER FROM THE ENDOTRACHEAL TUBE, AS CONTACT WITH SHARP EDGES ON THE INTERNAL SURFACE OF THE ENDOTRACHEAL TUBE MAY CAUSE SMALL FRAGMENTS TO BE SHAVED OFF THE CATHETER INTRODUCER DURING INTRODUCTION/REMOVAL. DESPITE ATTEMPTS TO RECEIVE THE DEVICE FOR INVESTIGATION IT WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION THE PHYSICIAN DECIDED TO USE A DOUBLE LUMEN ENDOTRACHEAL TUBE DURING THE PROCEDURE. THE IFU CLEARLY SPECIFY THAT THE FROVA DEVICE IS INTENDED FOR PLACEMENT WITH USE OF A SINGLE LUMEN ENDOTRACHEAL TUBE WITH AN INNER DIAMETER OF 6MM OR LARGER. NO EVIDENCE TO SUGGEST THAT THE DEVICE IS NOT MANUFACTURED ACCORDING TO SPECIFICATION COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING A DIFFICULT ORAL-TRACHEAL INTUBATION TO IMPLANT A LEFT-SIDE BRONCHO-CATH, WE DECIDED TO USE A FROVA TO INTUBATE THE PATIENT IN THE BEST POSSIBLE CONDITIONS. THE ORAL-TRACHEAL INTUBATION WAS SUCCESSFUL AND THE FROVA WAS REMOVED. WHEN CHECKING WITH A FIBROSCOPE, WE FOUND THAT A PIECE OF THE FROVA HAD REMAINED ON THE SIDE OF THE INTUBATION DEVICE. (DOUBLE ETT).
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 |
|---|---|---|---|---|---|---|---|
| 2470806 | FROVA INTUBATING INTRODUCER | BTR TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Life Threatening |