MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; BTR TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	G48303
Medical Device Problem Codes	Component Incompatible (1108); Flaked (1246); Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): k161813.Investigation is still in progress.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.
Event or Problem Description
Description of event according to initial reporter: use of the frova chuck.Fibroscopic control to see the correct position of the right 41fr s selective airway, blue chuck fragment fount in patients bronchus.Patient outcome: current state of the patient: extraction of the fragment using the fiberscope.Increased risk of infection.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).This is a correction due to lot#, which was mistakenly included in the previous report.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.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: during difficult intubation, the physician used a frova introducer with a double endotracheal tube.During fibroscopy a fragment of the blue introducer was found in the patient bronchus.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.According to the instructions for use the 14.0 french frova introducer has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.Furthermore, the ifu warn that the tube and the introducer must be lubricated before use and that care must be taken when introducing/removing the 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 catheter introducer during introduction/removal.There are adequate controls in place to ensure that this type of device is manufactured to specifications.The device was not returned for evaluation.Based on the provided information the physician decided to use a double lumen endotracheal tube during the procedure.The ifu clearly specify that the frova device is intended for placement with use of a single lumen endotracheal tube with an inner diameter of 6mm or larger.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: BTR TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16050126
• Report Number: 3002808486-2022-01062
• Device Sequence Number: 6200515
• Product Code: BTR
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)251114(10)E4332947
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2025
• Device Model Number: G48303
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: E4332947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/10/2023; 02/15/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 02/14/2023; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown