MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH; 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	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
A female patient of unknown age underwent a procedure for coil embolization in the renal artery.The device was advanced from the left common femoral artery to the renal artery.When attempting to perform the embolization, blood leaked from the tuohy-borst valve since the valve could not be closed after the user tightened the tuohy-borst valve.The device was replaced with another device to complete the procedure successfully.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection / functional testing of the returned device were conducted during the investigation.One used tuohy-borst valve was returned for investigation.After flushing the device, a leak test was performed by occluding the proximal end of the connecting tube and using a syringe to inject water through the distal end of the tuohy-borst valve.Leakage was detected at the junction between the connecting tube and cap.The connecting tube and cap were then separated, and a hole was found on the connecting tube just below the flare.It is feasible to suggest that the damage could have occurred during the flaring manufacturing process.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 were no other reported complaints for this lot number related to this issue.Based on the examination of the returned complaint device and the available information, the likely cause of the failure is manufacturing-related.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6039442
• Report Number: 1820334-2016-01136
• Device Sequence Number: 961404
• Product Code: DYB
• UDI-Device Identifier: 00827002301207
• UDI-Public: (01)00827002301207(17)190118(10)6529442
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-5.0-18/38-55-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1