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 Consequences Or Impact To Patient (2199)
Date of Event	02/26/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report.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.The preliminary investigation results have been sent today.We will update later if any further information is determined.A review of the complaint history, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One device was returned to assist in the investigation.Inspection of the device revealed the hub is separated from the flexor sheath.The flare of the flexor is of adequate size.The flare was slightly deformed which indicates that the flare was securely seated between the cap and adaptor.No creases were found in the flare indicating it had not been folded while inside the cap and adaptor.At this time, a definitive root cause cannot be determined.Additional investigation is pending.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
After the 7fr flexor raabe guiding sheath and dilator were accessed into the puncture site, the user was removing the dilator from the patient body and the sheath connecting joint separated from the check-flo valve.Therefore, the dilator is still inserted into the check-flo valve without the sheath cover.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.
Additional Manufacturer Narrative
A review of the complaint history, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One device was returned to assist in the investigation.Inspection of the device revealed the hub is separated from the flexor sheath.The flare of the flexor is of adequate size.The flare was slightly deformed which indicates that the flare was securely seated between the cap and adaptor.No creases were found in the flare indicating it had not been folded while inside the cap and adaptor.Based on the information received and the results of the investigation, it is feasible to suggest the device met with forces beyond its intended design.However, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6530950
• Report Number: 1820334-2017-00942
• Device Sequence Number: 13669731
• Product Code: DYB
• UDI-Device Identifier: 00827002116337
• UDI-Public: (01)00827002116337(17)170709(10)5117436
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 06/16/2017

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-7.0-38-55-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2015
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/16/2017; 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1