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	05/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Patient code; no impact or consequences to the patient were reported.Device code; separation is not labeled.The event is currently under investigation.
Event or Problem Description
During a filter removal procedure, the hub detached from the 12fr guiding sheath.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation a review of complaint history, device record history, instructions for use (ifu), quality control, specifications, trends and a visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: ¿before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Upon removal from package, inspect the product to ensure no damage has occurred.¿ it should be noted that there are no other complaints of any nature associated with this lot.The visual examination of the returned product and photographs demonstrated the hub is clearly detached from the dilator.It appears that the flare is under sized.This would be a manufacturing related failure.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
During a filter removal procedure, the hub detached from the 12fr guiding sheath.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5719963
• Report Number: 1820334-2016-00428
• Device Sequence Number: 18877280
• Product Code: DYB
• UDI-Device Identifier: 00827002562790
• UDI-Public: (01)00827002562790(17)190324(10)6837580
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2016

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-12.0-35-45-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 08/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other