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 Patient Involvement (2645)
Date of Event	09/23/2015
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 noted liquid permeation into the sidearm port of the check-flo body which is indicative of the hub separation while the device was being prepped for use.Additionally revealed, the hub is separated.The flare was folded on one side.The flare was measured to confirm adequate size.The correct cap and check-flo body were also applied.The cap was found to be of adequate size.No other notable damage was documented.With the present information a definitive root cause is undetermined.
Event or Problem Description
It was reported, upon opening the package, it was noted that the check flo valve was separated from the sheath.Prior to patient usage, no additional details have been received.
Additional Manufacturer Narrative
Additional evaluation was performed beyond that which was provided in the initial report.A review of the complaint history, device history record, and photographic inspection of the returned device was conducted during the investigation.The returned complaint device has been destroyed; however, photos of the returned device were examined for further evaluation.Review of the photos confirms the initial investigation that the device was separated at the proximal fitting to the flared tubing connection.The flare appeared to be appropriately sized and was folded on one side, but the cause of the folding could not be confirmed.There was a clear, colorless liquid noted in the sidearm port of the device; however, this liquid does not appear to be blood or bodily fluid.There was no noted blood or biomaterial on the device which supports the customer statement that the noted device failure occurred prior to patient contact.The original visual inspection is found to be appropriate for the photographic evidence review.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Measures have been conducted to address this failure mode.Based on the information provided and the results of our investigation; a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6291728
• Report Number: 1820334-2017-00254
• Device Sequence Number: 13843940
• Product Code: DYB
• UDI-Device Identifier: 00827002562325
• UDI-Public: (01)00827002562325(17)180421(10)5823117
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: No Information
• Device Model Number: N/A
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2015
• 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