MAUDE Adverse Event Report: COOK INC FROVA INTUBATING INTRODUCER

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: FROVA INTUBATING INTRODUCER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6100337
• MDR Text Key: 59835931
• Report Number: 1820334-2016-01307
• Device Sequence Number: 1
• Product Code: MQH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention