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

Catalog Number	C-CAE-14.0-70-FII
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
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.(b)(4).Investigation is still in progress.
Event or Problem 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.
Additional 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
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6753351
• Report Number: 3002808486-2017-01556
• Device Sequence Number: 19224560
• Product Code: DYB
• UDI-Device Identifier: 00827002236462
• UDI-Public: (01)00827002236462(17)190603(10)E3457472
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: E597079
• 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): 07/05/2017

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: No Information
• Device Catalogue Number: C-CAE-14.0-70-FII
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/20/2017
• Device Age: 13 MO
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 120