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

Model Number	G48303
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Occupation: sr.Clinical risk advisor.Similar to device marketed under pma/510(k): k161813 (b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: setting up for a double lumen procedure, 7fr double lube was being prepared by anesthesiologist and resident.A 14fr frova intubating catheter was placed inside the bronchial lumen to test for fit.Rt noted and vocalized that frova did not move smoothly within the lumen and mentioned that a 11fr exchange catheter was available.Anesthetist removed frova catheter and re-styletted double lumen in anticipation of intubation.Intubation performed and frova catheter not used.Once placement of double lumen, scope used to visualize airway placement.Bright blue foreign object noted in airway.Removed promptly by thoracic surgeon via suction on bronchoscope.Foreign body placed in specimen container and passed along to site lead along with frova catheter.Patient outcome: no apparent harm.
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: after placement of a double lumen tube a bright foreign object was noted in the airway and promptly removed by bronchoscope without further impact to the patient.A frova intubating introducer and an 8mm curly piece of the blue material were returned.The frova device was curved likely from return to fit into a smaller plastic pouch and an investigation revealed that 30mm of the material had peeled off 213mm from the proximal end.This peeling is likely from where the curly piece origins.Peeled frova material is mostly seen, if the frova intubating introducer is used for placement of a double lumen tube.However, it is noted that the intubation was performed without using the frova device and consequently based on the information provided the exact reason for the peeled material cannot be determined.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 and the ifu also warn not to use the frova intubating introducer with double lumen endotracheal or endobronchial tubes.It was assessed that because no non-conformances were detected, 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
• MDR Report Key: 11341639
• Report Number: 3002808486-2021-00126
• Device Sequence Number: 20082813
• Product Code: BTR
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)230527(10)E3987338
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 05/27/2023
• Device Model Number: G48303
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: E3987338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention