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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
Two performer introducers were used in an endovascular procedure.It was reported that, 700cc of blood was leaking through the valve of the introducers during the procedure.No additional treatment was required and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.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
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The complaint devices were not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished products were not made to specifications.Review of the device history record of the finished products shows no non-conformances.It should also be noted, there were no other reported complaints for this lot number.Based on the information provided, no products returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6950464
• Report Number: 1820334-2017-03534
• Device Sequence Number: 1297296
• Product Code: DYB
• UDI-Device Identifier: 00827002105386
• UDI-Public: (01)00827002105386(17)200807(10)NS8082796
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCFW-12.0-38-RB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 10/14/2017
• Supplement Report FDA Received Date: 01/08/2018
• 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: Other