FROVA INTUBATING INTRODUCER
Report
- Report Number
- 3002808486-2024-00198
- Event Type
- Injury
- Date Received
- September 27, 2024
- Report Date
- November 22, 2024
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. LITERATURE: ADINARAYANAN ET. AL. "SUCCESSFUL RETRIEVAL OF A SCALLOPED AIRWAY INTRODUCER FRAGMENT FROM THE TRACHEA USING A FIBEROPTIC BRONCHOSCOPE AND A URETERIC STONE RETRIEVER." DOI: 10.4103/JOACP.JOACP_360_20. 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.
MANUFACTURERS REF# (B)(4). LITERATURE: ADINARAYANAN ET. AL. "SUCCESSFUL RETRIEVAL OF A SCALLOPED AIRWAY INTRODUCER FRAGMENT FROM THE TRACHEA USING A FIBEROPTIC BRONCHOSCOPE AND A URETERIC STONE RETRIEVER." DOI: 10.4103/JOACP.JOACP_360_20. SUMMARY OF INVESTIGATIONAL FINDINGS: SYNOPSIS OF COMPLAINT: PIECES OF THE DEVICE BROKE OFF DURING ETT (DLT) EXCHANGE. THE PIECES WERE REMOVED WITH A STONE RETRIEVAL DEVICE. NO PRODUCT WAS RETURNED FOR INVESTIGATION BUT BASED ON THE INFORMATION AND THE PHOTOS PROVIDED IN THE ¿LETTER TO EDITOR¿ THE FROVA INTRODUCER SHAVED OFF BITS, WHEN USED WITH DOUBLE LUMEN TUBES. ACCORDING TO THE INSTRUCTIONS FOR USE SUPPLIED WITH ANY 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. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS 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 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.
DESCRIPTION OF EVENT ACCORDING TO LITERATURE: SYNOPSIS OF COMPLAINT: PIECES OF THE DEVICE BROKE OFF DURING ETT EXCHANGE. THE PIECES WERE REMOVED WITH A STONE RETRIEVAL DEVICE. (PAGE 1, COLUMN 1, LOWER PARAGRAPH 1 TO PAGE 1, COLUMN 2, PARAGRAPH 2).
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 |
|---|---|---|---|---|---|---|---|
| 1432754 | FROVA INTUBATING INTRODUCER | BTR TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | WILLIAM COOK EUROPE | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention |