MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL 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	05/29/2015
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, dimensional verification, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.One flexor high-flex ansel guiding sheath was returned to assist in the investigation.Inspection revealed the flare was of adequate size.The flare was slightly stretched on outer edges.This indicates the flare was caught securely between the cap and adaptor assembly.The cap and adaptor assembly was screwed together with the cap and adaptor being flush with each other.No noticeable damage was found on the sheath length.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
International customer reported that valve loosened and separated from the sheath.This occurred when introducing the dilator in the sheath prior to patient contact.No adverse patient consequences were reported.No further event or patient information was provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the device history record and a photographic inspection of the returned device were conducted as part of an additional investigation of the complaint device.The returned complaint device was destroyed after completion of the initial investigation, in accordance with the disposition procedure for the device.Photos of the returned complaint device were later examined as part of further investigation into the reported incident.The returned device showed no sign of blood or biomaterial on the sheath, side arm, stopcock, or check flo valve.The check flo valve assembly had separated from the shaft of the sheath at the hub connection.The flare was slightly stretched on outer edges.This stretching is likely to be caused when the flare is caught between the cap and adaptor assembly.The visual inspection of the device which was performed previously was consistent with the photographic evidence reviewed as part of the additional investigation, which was reported in the initial report.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our additional investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Measures have been previously conducted to address this failure mode.

• 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: 6291708
• Report Number: 1820334-2017-00242
• Device Sequence Number: 1105750
• Product Code: DYB
• UDI-Device Identifier: 00827002490451
• UDI-Public: (01)00827002490451(17)180416(10)5810217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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: KCFW-8.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1