MAUDE Adverse Event Report: COOK INC FROVA INTUBATING INTRODUCER; LRC CHANGER, TUBE, ENDOTRACHEAL

Catalog Number C-CAE-8.0-35-FII

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the tip of a frova intubating introducer broke off and was unintentionally left in the airway of the patient.On (b)(6) 2021 at 8 p.M., the physician attempted to intubate a (b)(6)-month old patient with an 8fr catheter for the purpose of mri scanning.The patient was not intubated prior.Resistance was experienced while attempting to intubate; however, the physician reportedly did not use great force to advance the introducer.After the second advancement attempt, the introducer was removed easily.It was not realized at that time that the tip of the catheter had broken off and was left in the airway of the patient.The patient was then transferred to another facility that day.A physician at the new facility then removed the section of the catheter left behind in the airway.As reported, the "patient is fine".

Manufacturer Narrative

Investigation ¿ evaluation.It was reported by (b)(6) hospital that the catheter broke and the tip was left inside the patient¿s airway.The patient was a four-month-old female and the complaint device was a frova intubating introducer (rpn: c-cae-8.0-35-fii, lot number unknown).On (b)(6) 2020, the physician attempted to intubate the patient using a frova intubating introducer.The patient was not intubated prior to using the device.The patient was in need of a magnetic resonance imaging (mri) scan.During the procedure, the physician experienced resistance while trying to intubate the patient.It was reported that ¿great force¿ was not applied to advance the introducer.After second attempt, he was able to easily remove the introducer.The frova intubating introducer broke, and a portion was left in the patient¿s airway.However, this was not noticed before the patient was transferred to hospital sultanah bahiyah.After the transfer, another physician removed the portion that was left in the patient.It was reported that the patient outcome was ¿fine.¿ a review of the instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be completed.However, photos of the broken device and an x-ray of the patient¿s chest showing the retained portion of the device were provided by the facility.The catheter was observed to be separated into two sections.The distal section was several centimeters long and the proximal section showed that the stiffening cannula has been exposed.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.A review of the device history record (dhr) could not be completed, due to the lack of lot information from the facility.As adequate inspection activities have been established and no other lot related evidence is available, it was concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information related to the reported failure mode: "intended use: the cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchange.Warnings: -attention should be paid to insertion depth of the catheter into patient`s airway and correct tracheal position of replacement endotracheal tube.Catheter and endotracheal tube should not be advanced beyond the carina.-ensure proper sizing of the cook airway exchange catheter within a double-lumen endotracheal tube.Failure to do so may cause small fragments to be shave off during removal of the cook airway exchange catheter.Precautions: ¿.Standard techniques for placement and exchange of endotracheal tube should be employed.Endotracheal tube exchange: 7.Remove the cae catheter and inflate the balloon cuff of the new endotracheal tube.Confirm its position using standard methods (e.G.Capnography, breath sounds and chest x-ray)".Based on the information provided, no returned product, and the results of our investigation, a definitive cause for the failure could not be established.The most likely cause of this event could be traced to the medical procedure, although it is not possible to rule out the use of an expired device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11436273
• MDR Text Key: 238392554
• Report Number: 1820334-2021-00904
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-8.0-35-FII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO