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 Information (3190)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).510(k): k161813.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: during the time of insertion with the help of laryngoscope the distal end was fractured.Fractured near the tip and then procedure was completed in conventional way of intubation.Patient outcome: the product did cause/contribute to the need for additional procedure: conventional endotracheal intubation.Please specify adverse effect(s) and provide details: delay in the time for securing airway.
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).Summary of investigational findings: it was reported that the distal end of the frova device fractured, when inserted with laryngoscope.The procedure was completed with conventional endotracheal intubation, causing prolonged procedure.Only very limited information was provided and since the actual complaint device was not returned, it would be inappropriate to speculate at what may or may not have caused the distal end to fracture, when inserted with an unknown laryngoscope.According to the instructions for use it is contraindicated not to use the frova device ¿if the epiglottis cannot be visualized when performing laryngoscopy, i.E.Grade iv cormack & lehane laryngoscopy classification.¿ and under instructions for use: using laryngoscopy, introduce the tip of the catheter introducer beyond the epiglottis and advance it in a straight line towards the glottis.There are adequate controls in place to ensure the 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
• MDR Report Key: 9543534
• Report Number: 3002808486-2020-00001
• Device Sequence Number: 14037008
• Product Code: BTR
• UDI-Device Identifier: 00827002236462
• UDI-Public: (01)00827002236462(17)220527(10)E3857801
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 05/27/2022
• Device Model Number: G23646
• Device Catalogue Number: C-CAE-14.0-70-FII
• Device Lot Number: E3857801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 50