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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, drawings, dimensional verification, specifications, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The sheath and the 0.038" dilator were returned in used, damaged condition.The dilator was returned fully inserted into the sheath and the tuohy-borst connector was fully tightened around the shaft of the dilator.Biomatter was present.Hangnail damage was noted distally on the sheath.No other damage was noted.The inserted dilator extended past the distal tip of the sheath approximately 4.2 cm.The outer diameter of the dilator was measured within specifications.It was not possible to confirm the inner diameter of sheath at distal transition to dilator due to sheath distal tip hangnail damage.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 failure mode on this lot number.Further investigation is pending.A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.
Event or Problem Description
It was reported that during an unspecified procedure, access was gained from the femoral artery to the lesion of iliac artery, superficial femoral artery and below the knee contralaterally.After placement of a competitor¿s wire guide and short sheath (4fr), an attempt was made to advance the flexor ansel guiding sheath.However, it would not advance into the patient's body because it was reportedly dull.There was also a gap between the dilator and the sheath.A competitor¿s device was used instead to complete the procedure.Further information was ascertained that there was distal hangnail damage at the tip of the sheath.There was no adverse effect to the patient reported.
Additional Manufacturer Narrative
Per the ifu: "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt." based on the available information and results of the investigation the root cause of the reported event may be related to the patient's pre-existing condition (atherosclerosis) and user technique.Per the health risk assessment, no further action is required.Monitoring for similar complaints will continue.

• 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: 6630033
• Report Number: 1820334-2017-01232
• Device Sequence Number: 495538
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)190628(10)7080682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2017

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-6.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/26/2017; 06/26/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 07/20/2017; 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1