MAUDE Adverse Event Report: COOK INC FLEXOR 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)
Date of Event	07/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).Investigation - evaluation: a review of the complaint history, specifications, trends and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device is shipped with an instruction for use (ifu) that describes the intended use, lists warnings and precautions as well as instructions for proper use and placement of this device.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.
Event or Problem Description
Customer reported that a male patient underwent a transjugular liver biopsy.After initial placement of the device, the attending physician retracted the device and attempted to curve the tip.The dilator was in the sheath while curving the device.The distal tip of the dilator separated while it was outside of the patients body.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.

• Brand Name: FLEXOR GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6291275
• Report Number: 1820334-2017-00246
• Device Sequence Number: 552908
• Product Code: DYB
• UDI-Device Identifier: 00827002322332
• UDI-Public: (01)00827002322332(17)180407(10)5782518
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2015

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-10.0-38-40-RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2015
• Initial Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1