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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2017
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
A flexor introducer sheath was used during a superficial femoral artery procedure via contralateral access.It was reported that the hub separated from the sheath during removal.A wire guide was being used; however, they did not use a dilator.The sheath and hub were removed and replaced with a short sheath, 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, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, inspection of unused product, visual inspection and functional testing of the returned devices was conducted during the investigation.The complaint device was not returned to aid the investigation as it was discarded by the user facility.However, there were nine unused unopened devices returned.Six flexor introducer sheaths were from the same lot as the complaint 7794481, two devices from lot 5809455 and one device from lot 7993358.There were no nonconformities on the device surface when inspected visually.There was a destructive pull test performed on the devices.Each device passed the test since it met the tensile requirements.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record for lot 7794481, shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The process of attachment of the hub to the sheath is validated and meets the industry standards.Once the device has been manufactured it undergoes 100% inspection to verify the attachment of proximal fitting.Based on the information provided, no complaint device 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 required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6950466
• Report Number: 1820334-2017-03558
• Device Sequence Number: 1406125
• Product Code: DYB
• UDI-Device Identifier: 00827002098091
• UDI-Public: (01)00827002098091(17)200331(10)7794481
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: KCFW-6.0-38-45-RB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 10/14/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1