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

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
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
It was reported that during preparation for an unknown procedure, upon opening the package, there was a cut/tear observed at the shaft-hub junction of the flexor ansel guiding sheath.The device was not used, there was no patient involvement.No adverse events have been reported regarding this complaint device.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The sheath and both dilators of the flexor ansel guiding sheath were returned.The tubing of the sheath is separated at the hub, but it is connected by exposed coil.The connector cap was disassembled from the check-flo body to examine for non-conformities.The check-flo body broke when attempting to disassemble it from the connector cap.The sheath tubing measured 89.5cm, hence built under specification and along with the exposed coil it measured 90.0cm 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.Flexor ansel guiding sheaths are inspected 100% for defects prior to transport.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause was determined to be related to package handling and storage.Measures have been initiated to address this failure mode.The appropriate personnel have been notified and 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: 6794453
• Report Number: 1820334-2017-02607
• Device Sequence Number: 16173337
• Product Code: DYB
• UDI-Device Identifier: 00827002481893
• UDI-Public: (01)00827002481893(17)200321(10)7765987
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/09/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: KCFW-5.0-18/38-90-RB-ANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1