MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE TIBIAL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.(b)(4).The event is currently under investigation.
Event or Problem Description
Sideport vents leaked during the procedure.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, dimensional verification, functional testing, device record history, manufacturing instructions, documentation, quality control and a visual inspection of the returned device was conducted during the investigation.One connecting tube was returned to assist in the investigation.The device was liquid leak tested in order to attempt to recreate the failure.It was found that the connecting tube leaked just distal of the cap if sufficient pressure was applied to the device.The nature of the leak was slow allowing for a water bubble to form distal of the cap.The connecting tube was disassembled and the flare was visually inspected.The visual examination reported the flare appeared uneven/slanted.Additionally, there appeared to be a nick in the material and the flare appeared frayed at the ends.There was "hole-like" damage just distal of the flare; however, the damage was not all the way through the material.Based on the evaluation of the returned complaint device, the root cause was determined to be related to manufacturing - operator related.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment (ra) no further action is required.
Event or Problem Description
Sideport vents leaked during a carotis intervention procedure.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 SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5497335
• Report Number: 1820334-2016-00140
• Device Sequence Number: 1134941
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)181118(10)6390012
• Combination Product (Y/N): N
• 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): 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 06/27/2016
• 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