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 Consequences Or Impact To Patient (2199)
Date of Event	10/30/2015
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).The reported device returned for evaluation.Visual inspection note, the flare was well formed an met specification when measured using a go-no-go gauge.The root cause is not able to be determined.
Event or Problem Description
It was reported that while the sheath was inserted and the doctor was manipulating the wire, the hub/check flo valve snapped off.The sheath was removed and another sheath was inserted.The patient remained unharmed.No additional details have been provided.

• 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: 6290961
• Report Number: 1820334-2017-00257
• Device Sequence Number: 932573
• Product Code: DYB
• UDI-Device Identifier: 00827002299856
• UDI-Public: (01)00827002299856(17)170826(10)5237822
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2015

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-7.0-18/38-45-RB-ANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2015
• 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
• Patient Age: 82 YR