MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number C-CAE-14.0-70-FII

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2017

Event Type  malfunction  

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: "2 trials with videolaryngoscope and frova was not successful caused of kinking.The 3rd frova from a different charge was then successful".Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned products.The stiffening stylet was still placed inside the used catheter and investigation revealed a kink on the catheter approx.10cm from the distal tip, exactly in the area of the stiffening stylet tip.No damages/kink were noted on the unopened device.Based on these findings it is suggested that the stiffening stylet was not removed at the right time or the catheter was exposed to manipulation beyond its intended design during advancement.No evidence to suggest that this frova 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.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6753353
• MDR Text Key: 81376505
• Report Number: 3002808486-2017-01580
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002236462
• UDI-Public: (01)00827002236462(17)190718(10)E3473483
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C-CAE-14.0-70-FII
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/20/2017
• Device Age: 12 MO
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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 Weight: 120