MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-11-14 for FROVA INTUBATING INTRODUCER N/A UNKNOWN manufactured by Cook Inc.
[59835931]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59835932]
C. T. D. Goodman et al: anaesthesia, journal of the association of anesthetists of great britain and ireland anaesthesia, 2009, 64, pages 216229. The above referenced journal article alleged that fragments were found in the patients vocal cords and the patient was serendipitously endoscoped after intubation. "a grade 3 view of the larynx was seen at laryngoscopy and a bougie, a frova airway intubating was required. Its angled tip cannot be threaded through the connector of tracheal tubes < 6 mm, so a 6-mm tracheal tube was selected. The passage of the bougie through the armoured tracheal tubes connector, angled-end first, was tested before use. Intubation then proceeded, by railroading the tracheal tube over the bougie. On bronchoscopy, the surgeon discovered and retrieved blue plastic shavings below the vocal cords. The same material also adhered to the inner aspect of the 15-mm tracheal tube connector, the edge of which was particularly sharp. It had shaved plastic from the bougie, evidenced by scratches proximal to the bougies angulation (fig. 1a,b). " the manufacturer publish a users booklet stating that an appropriately sized lubricated endotracheal tube is preloaded on the proximal (nonangled) part of the bougie. It goes on to advocate against the use of double lumen tubes and warns of fragments being shaved from the bougie on its removal. This bougie is in one size only and there is no specification from the manufacturers regarding compatibility of tracheal tubes. Even with lubrication, plastic tendrils were shaved with ease when threaded through the connector when we tried it. Removing the bougie from the tracheal tube also caused this. It seems likely that fragments were scratched off during pre-use testing and pushed into the trachea during intubation and ventilation. Even if inert, these would cause irritation and inflammation.
Patient Sequence No: 1, Text Type: D, B5
[75850426]
Investigation - evaluation: a review of the drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly, a review of the device history record could not be conducted. The device is shipped with instruction for use (ifu) which notes: "ensure proper sizing of the endotracheal tube to be used in combination with the frova intubating introducer," and "care must be taken when introducing/removing the catheter introducer from the endotracheal tube; 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. " based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-01307 |
| MDR Report Key | 6100337 |
| Report Source | LITERATURE |
| Date Received | 2016-11-14 |
| Date of Report | 2017-05-17 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2016-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FROVA INTUBATING INTRODUCER |
| Product Code | MQH |
| Date Received | 2016-11-14 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-14 |