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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2015
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, quality control and visual inspection of the returned device was conducted during the investigation.One flexor high-flex ansel guiding sheath and dilator was returned to assist in the investigation.The device was returned with the dilator inserted into the sheath.A separation in the sheath was noted approximately 16 cm from the sheath tip.The material is torn and fragmented at the separated section.The inner liner is also separated and the coils are showing, however the coils were not broken.No other damage was noted.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.
Event or Problem Description
Customer reported that the device was placed into the common femoral for an unspecified procedure.A dilator was placed within the lumen of the sheath prior to removal from the patient.The device reportedly began to unravel upon removal of the sheath.The sheath was removed and replaced with a new device to complete the procedure.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 HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6291718
• Report Number: 1820334-2017-00249
• Device Sequence Number: 1563602
• Product Code: DYB
• UDI-Device Identifier: 00827002562226
• UDI-Public: (01)00827002562226(17)170917(10)5289374
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2015

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-7.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OCELOT PIXL CROSSING CATHETER