MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported during a peripheral angiography procedure using a flexor ansel guiding sheath, the hub of the sheath came off when they were trying to reposition.The device was taken off over the wire and a new device was opened and placed over the wire.The procedure was finished successfully with the new device.No section of the device remained inside the patient's body.There were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Additional information: device available for evaluation.A review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), specifications, and visual inspection of the returned device was conducted during the investigation.A used flexor ansel guiding sheath (kcfw-6.0-18/38-45-rb-anl2-hc) was returned for investigation.The dilators were not present.The connector cap is separated from the sheath tubing.A 2mm compression is present 8mm from the proximal end.3.2 cm from the distal end, a protrusion is noted.The flare is undamaged.The check-flo body was disassembled from the connector for further examination.No nonconformities were noted.The inner diameter of the connector cap is within specification.Instructions for use states, "warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Precautions: this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt." 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.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: 6736733
• Report Number: 1820334-2017-01870
• Device Sequence Number: 16496804
• Product Code: DYB
• UDI-Device Identifier: 00827002299832
• UDI-Public: (01)00827002299832(17)200512(10)7907306
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/23/2017

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-6.0-18/38-45-RB-ANL2-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1