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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that during a peripheral intervention, the valve / side port of a flexor introducer sheath leaked excessively when placed at the femoral site.It leaked with each pulse.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, visual inspection and functional testing of the returned device was conducted during the investigation.A flexor introducer sheath was returned in a used condition.The dilator was returned inserted into the sheath.A leak test was performed.Leakage was detected from the check-flo valve.The check-flo valve was disassembled and no non-conformances were noted.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that during a peripheral intervention, the valve / side port of a flexor introducer sheath leaked excessively when placed at the femoral site.It leaked with each pulse.A new sheath was used to complete the case.There was no additional medical intervention required due to the blood loss.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6521729
• Report Number: 1820334-2017-00786
• Device Sequence Number: 340054
• Product Code: DYB
• UDI-Device Identifier: 00827002088672
• UDI-Public: (01)00827002088672(17)200111(10)7581476
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-6.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1