MAUDE Adverse Event Report: COOK INC FLEXOR RAABE 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	06/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The valve was detached from the sheath during the procedure.The user facility replaced the device with a new device to finish the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, drawings, dimensional verification, documentation, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.One used/damaged kcfw-8.0-38-55-rb-raabe was returned with an inserted dilator.The flare did not appear to be distorted.The flare dimension was tested using a go/ no-go flare gage and passed; thus confirming the flare was made to specification.The dimension of the connector cap was measured using a pin gauge and was found to be out of specification.Review of device history record shows 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, examination of the returned device and the results of our investigation, it is feasible to suggest that the sheath separated from the valve due to the device being manufactured with an inappropriate sized connector cap.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
The valve was detached from the sheath during the procedure.The user facility replaced the device with a new device to finish the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5775921
• Report Number: 1820334-2016-00582
• Device Sequence Number: 18910881
• Product Code: DYB
• UDI-Device Identifier: 00827002122420
• UDI-Public: (01)00827002122420(17)180527(10)5911400
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2016

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-8.0-38-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2016
• Supplement Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70