FROVA INTUBATING INTRODUCER
Report
- Report Number
- 3002808486-2023-00231
- Event Type
- Injury
- Date Received
- August 31, 2023
- Report Date
- October 27, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURERS REF (B)(4) G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K161813. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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: WHEN USED WITH DOUBLE LUMEN TUBE THE FROVA BOUGIE SHAVING OFF BITS OF PLASTIC INTO THE PATIENTS BRONCHUS. HAPPENED AS MANY AS 8 TIMES, BUT AS TO PATIENT HARM OR OUTCOME NO INFORMATION WAS PROVIDED. NO PRODUCT WAS RETURNED FOR INVESTIGATION, BUT BASED ON THE INFORMATION PROVIDED THE FROVA INTRODUCER SHAVED OFF BITS, WHEN USED WITH DOUBLE LUMEN TUBES. ACCORDING TO THE INSTRUCTIONS FOR USE SUPPLIED WITH THE FROVA INTRODUCER IT IS DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6MM OR LARGER AND THE IFU ALSO WARN THAT THE CATHETER INTRODUCER AND THE ENDOTRACHEAL TUBE MUST BE LUBRICATED BEFORE USE AND THAT CARE MUST BE TAKEN WHEN INTRODUCING/REMOVING THE CATHETER 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 INTRODUCER. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT TO FOLLOW-UP WITH THE CUSTOMER AND TO ADDRESS THE FEEDBACK AS WELL AS THE USE OF THE FROVA INTRODUCER. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE TYPE OF DEVICE WAS MANUFACTURED TO SPECIFICATIONS. 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. 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: THE PHYSICIAN MENTIONED THAT THEY HAD REPORTED TO COOK THAT THEY HAD A FEW INSTANCES OF THE FROVA BOUGIE SHAVING OFF BITS OF PLASTIC INTO THE PATIENTS BRONCHUS. THE PHYSICIAN MENTIONED IT COULD HAVE HAPPENED AS MANY AS 8 TIMES. THEY ARE NOW AWARE NOT TO USE THE FROVA BOUGIE WITH DOUBLE LUMEN TUBES (DLT) AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE HOSPITAL HAS NOW SWITCHED AWAY FROM THE FROVA AND IS NOW STOCKING ANOTHER BOUGIE THAT THEY CLAIM IS INDICATED FOR DLTS. THE PHYSICIAN HAD RECALLED APPROX. 3 INSTANCES WHERE THE FROVA BOUGIE HAS SHAVED OFF. PATIENT OUTCOME: UNKNOWN
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 |
|---|---|---|---|---|---|---|---|
| 1438184 | FROVA INTUBATING INTRODUCER | BTR TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |