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	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.G5) similar to device 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: customer is complaining that the pieces of the product stayed inside the lung during the bronchoscopy.Patient intubated with the help of frova.Afterwards a double lumen tube was placed over the frova.During the subsequent bronchoscopy, a foreign body was found in the lung and removed.Because of the colour it is assumed to be a piece of the frova.This wasn't the first time this had happened.Patient outcome: during bronchoscopy a piece of frova was found in the lungs and salvaged.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Summary of investigational findings: the investigation is based on event description only.It was reported that after intubating with the frova introducer, a doube lumen tube was advanced and during bronchoscopy a foreign body was found in the lung and removed.No adverse effects to the patient were reported.The frova introducer was not returned for investigation, but two photos of a small, blue piece of material were provided and it is considered likely, that the blue piece on the photos were flakings, which derived from the frova introducer.Based on the photos only the exact reason for the flaking off of the introducer cannot be determined, but since the introducer was used for placement of a double lumen tube, this is considered the likely cause of this occurrence.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.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." no evidence to suggest that the frova introducer 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: 8564008
• Report Number: 3002808486-2019-00507
• Device Sequence Number: 11350143
• Product Code: BTR
• UDI-Device Identifier: 00827002236462
• UDI-Public: (01)00827002236462(17)210524(10)E3729541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/24/2019

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: 05/24/2021
• Device Model Number: G23646
• Device Catalogue Number: C-CAE-14.0-70-FII
• Device Lot Number: E3729541
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/08/2019
• Device Age: 10 MO
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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