MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; LRC INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number C-CAE-14.0-70-FIC

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: during a conference, an anesthetist reported to a cook medical representative that 8 years ago at the healthcare facility, a patient was oxygenated down a frova bougie.However, the bougie was inserted too far down, the oxygen that was administered was high pressure and the patient died as a result.Patient outcome: patient died.

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: no product was returned, no imaging was provided, and attempts to obtain additional information were unsuccessful.It was reported that the patient died, but the actual cause of death is unclear, eg pneumothorax with tension, gas emboli, etc.Also, it is unknown, why oxygen was used at high pressure down the frova in first place.Consequently, based on very limited information provided the exact reason for the incident cannot be determined, but it is noted that the physician considered it a mis-use of the device.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: during a conference, an anesthetist reported to a cook medical representative that 8 years ago at the healthcare facility, a patient was oxygenated down a frova bougie.However, the bougie was inserted too far down, the oxygen that was administered was high pressure and the patient died as a result.Patient outcome: patient died.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7547985
• MDR Text Key: 109358202
• Report Number: 3002808486-2018-00611
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: E597079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/10/2018
• Date Manufacturer Received: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death