MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G13495
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient code: no information regarding the event has been provided.Device code: material separation is not listed in the instructions for use (ifu).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
As reported to customer relations, the performer introducer appeared to be leaking blood out of the valve during the procedure.Additional intervention or procedures were not conducted, and no adverse events have yet to be reported.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number for an unrelated failure mode.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6670890
• Report Number: 1820334-2017-01573
• Device Sequence Number: 10913543
• Product Code: DYB
• UDI-Device Identifier: 00827002134959
• UDI-Public: (01)00827002134959(17)191104(10)7418794
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: G13495
• Device Catalogue Number: RYCFW-6.0-35-6-CW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 10/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other