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); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
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.Reporter occupation: safety officer.Similar to device marketed under pma/510(k): k161813.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: shavings of blue plastic found in the patients bronchus, when performing bronchoscopy.Origins of plastic fragments unclear, suspicious that it might originate from blue cook bougie - catheter.We turned the patient into the lateral position for the second stage part of the case.During this process of checking the position of the double lumen tube, a blue object could be seen in the right lower lobe bronchus.Surgical team were informed and viewed the object via the scope.Surgical team and anesthetic team discussed this with the thoracic surgeon.The decision was made to remove and retrieve the foreign object via a bronchoscopy.Thoracic surgeon checked the left lobe and more plastic was retrieved.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Manufacturer ref# (b)(4).Summary of investigational findings: shavings of blue plastic, likely from frova device, were found in the patient¿s bronchus.Removed by bronchoscope without any noted injuries to the patient.No product was returned for investigation and without the actual complaint device it would be inappropriate to speculate at what may or may not have caused the shavings.However, it is noted that the introducer was used for placement of a double lumen tube and according to the instructions for use, the frova introducer has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6mm or larger.Therefore, the use of the dlt is considered the likely cause of this occurrence.Ifu, intended use: "the 14.0 french catheter introducer has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger." note: "do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." warnings: "do not use the frova intubating introducer with double lumen endotracheal or endobronchial tubes." there are adequate controls in place to ensure that this device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.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.

• 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 ; 56868686
• MDR Report Key: 12638050
• Report Number: 3002808486-2021-01864
• Device Sequence Number: 11892811
• Product Code: BTR
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)240114(10)E4061374
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: G48303
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: E4061374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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: Female