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

Model Number	G53517
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Similar to device under pma/510(k) k161813.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: case of a difficult intubation planned for an obese patient, here is the procedure: using a video blade from another manufacturer: nothing to report.The tracheal tube is not positioned correctly to intubate use of the frova, it did not go into the trachea.Good visualization of the vocal cords but the mandrel could not be set up.Abandonment of this technique.Use of an articulated blade and simple intubation mandrel.It is the second complaint with the same problem the frova is too soft.Patient outcome: the patient did not require any additional procedures due to this occurrence.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: the investigation is based on the event description and three unused devices.It was reported that the frova device was too soft and would not go into the trachea.The procedure was abandoned and another tube was placed.The used frova device was not returned, but three unopened/unused devices from the same lot.The pouches were slightly discolored, but a thorough investigation of the three devices did not reveal any non-conformances and they were all found manufactured according to specifications, with a smooth surface and no soft appearance.The spops devices are curved to fit in slip peel-pouches and even after slight manipulation the devices maintained their curve.Therefore, it would be inappropriate to speculate at what may or may not have caused the frova device to appear soft and difficult to advance into the trachea as reported.There are adequate controls in place to ensure the device was manufactured 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.

• 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: 9361486
• Report Number: 3002808486-2019-01848
• Device Sequence Number: 16800964
• Product Code: BTR
• UDI-Device Identifier: 00827002535176
• UDI-Public: (01)00827002535176(17)220729(10)E3880024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 07/29/2022
• Device Model Number: G53517
• Device Catalogue Number: C-CAE-14.0-70-FIC-SPOPS
• Device Lot Number: E3880024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1