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

Model Number	G23646
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k) k161813.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: the patient was intubated with the frova introducer which was then removed.During a check of the airways, an object was seen and once removed it was deemed to be part of the introducer.They called the pulmonology to remove the piece of device remained in the main bronchus.Patient outcome: the small piece has been removed, without any inconvenience.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).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
Additional informtion received 11dec2019: it was a single lumen tube at the procedure.
Additional Manufacturer Narrative
Manufacturer ref# pr286515 summary of investigational findings: the investigation is based on event description and analysis of the returned device.It was reported that after placement of a single lumen tube an object deemed to be part of the frova was seen in the airways.The part was removed from the bronchus with no reported harm to the patient.A used frova introducer was returned with the stylet inside and with a small 5.5mm curly piece of the frova as reported.During investigation two shavings were noted on the frova - one piece 50mm long at the proximal end - one piece 10mm long close to a side hole immediately, the exact reason for the shavings cannot be determined.Reportedly the introducer was used for placement of a single lumen tube, but there is no information provided concerning the tube itself or its inner diameter.According to the instructions for use the frova device is intended for placement of a single lumen endotracheal tube whose inner diameter is 6mm or larger and also, the ifu warn that the catheter introducer and the endotracheal tube must be lubricated before use.The device history record was reviewed with no evidence to suggest that the device was not manufactured according to specifications.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.
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
• MDR Report Key: 9449298
• Report Number: 3002808486-2019-01951
• Device Sequence Number: 3077809
• Product Code: BTR
• UDI-Device Identifier: 00827002236462
• UDI-Public: (01)00827002236462(17)191206(10)E3528140
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2020

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: 12/06/2019
• Device Model Number: G23646
• Device Catalogue Number: C-CAE-14.0-70-FII
• Device Lot Number: E3528140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 05/26/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/11/2019; 06/09/2020
• 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: Life Threatening