MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	C-CAE-14.0-70-FIC
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).A1) unknown as information was not provided.A2) unknown as information was not provided.A3) unknown as information was not provided.A4) unknown as information was not provided.E2) unknown as information was not provided.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.G5) similar to device under 510(k): e597079.(b)(4).Investigation is still in progress.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.
Event or Problem Description
Description of event according to initial reporter: during fibroscopic control: a chip of the device was found.Fibroscopic aspiration and retrieval of the fragment.Additional information received 04apr2017: intubation on guide by bronchocatheter 37g without spur lubricated without problem.During fibroscopic control: a chip of the device was founded.Fibroscopic aspiration and retrieval of the fragment.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.
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Summary of investigational findings: investigation is based on the event description and returned product.An investigation of the returned device confirmed a small part had sheared off at the distal end of the catheter introducer (photo attached).However, the frova introducer was used with a double lumen et tube.The frova introducer is designed for placement of a single lumen tube only - not a double lumen tube as reported.No evidence to suggest that the device was not manufactured according 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.
Event or Problem Description
Additional information received 02jun2017: the device was used with it was use with a double lumen tube endotracheal tube.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6479556
• Report Number: 3002808486-2017-00944
• Device Sequence Number: 13752584
• Product Code: JOH
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)191117(10)E3521538
• 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): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/28/2017
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention