MAUDE Adverse Event Report: COOK INC COOK ACCESS PLUS LUER-LOCK HIGH-VOLUME INFUSION INTRODUCER SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	11/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this report indicate the information is unknown or unavailable.(b)(4).Event is still under investigation at this time.
Event or Problem Description
The (b)(6) male patient was at hospital (#1) for ecmo (extra corporeal membrane oxygenation).Ecmo is a form of extracorporeal life support where an external artificial circuit carries blood from the patient to a gas exchange (oxygenator) and becomes enriched with oxygen, and carbon dioxide is removed.The blood then re-enters the patient circulation.Ecmo circuit blood is optimized to provide adequate patient support in the absence of native lung or heart function¿.This is a specialized treatment; which cannot be performed at the above mentioned hospital; therefore, ecmo retrieval personnel from another hospital (#2) came with equipment and the required product to perform this procedure.The user inserted the cook backflow cannula in the right superficial femoral artery on (b)(6) 2016.The patient was then transferred to the icu of the facility (#2).Approximately four hours post insertion, an icu doctor was inspecting the dressing/insertion site of the back flow cannula and moved the patient's leg, when the hub separated (came apart) from the catheter, causing an arterial hemorrhage.The doctor applied pressure, the catheter was rewired and a new device inserted.The catheter remained in the femoral artery until a new catheter was rewired/inserted.It is unknown if there are any adverse effects, the patient remains on ecmo.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, manufacturing instructions, specifications, and quality control was conducted during the investigation.Eight unopened devices from 2 different lots other than the reported device lot were returned to assist with this investigation.The devices were tensile tested to failure.All of the devices were found to meet the required minimum straight line tensile forces per iso specification; no device failures were noted.The actual complaint device nor samples from the suspect lot were returned for evaluation therefore, no physical examinations could be performed for the reported lot; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no actual product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Measures have been initiated to address the issue.

• Brand Name: COOK ACCESS PLUS LUER-LOCK HIGH-VOLUME INFUSION INTRODUCER SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6150877
• Report Number: 1820334-2016-01488
• Device Sequence Number: 16366101
• Product Code: DYB
• UDI-Device Identifier: 00827002074040
• UDI-Public: (01)00827002074040(17)180828(10)6162595
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-FSSI-9.0-35-J-10.5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 06/15/2017
• 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
• Patient Age: 50 YR