MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE TIBIAL 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	02/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Information was provided that the (b)(6) male patient with a preexisting condition of cia (a common iliac artery aneurysm) had a flex graft and a right iliac branch device (ibd) inserted in 2011.The patient required an additional ibd to left cia; therefore, required a long sheath inserted via the axillary artery.When the 8fr shuttle sheath was inserted into the axillary artery, the sheath separated over the wire from the white hub at the proximal end.The sheath had to be removed and a second 8fr sheath was opened and used for the remainder of 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, visual inspection, device history record, documentation, manufacturing instructions and quality control was conducted during the investigation.There is no evidence to indicate the product was not manufactured according to specifications.One 8.0 french sheath and dilator were returned with the hub separated from the sheath.The returned complaint device was visually and dimensionally inspected.The cap pin was gauged and determined to be within specification.The flare size was adequate as verified by the appropriately sized flare go no-go gauge.However, the flare did appear slightly elongated on one side, which was likely due to being pulled from the cap.Based on the information provided and the returned complaint device, it is likely the device experienced forces beyond it's design.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
Information was provided that the (b)(6) year old male patient with a preexisting condition of cia (a common iliac artery aneurysm) had a flex graft and a right iliac branch device (ibd) inserted in 2011.The patient required an additional ibd to left cia; therefore, required a long sheath inserted via the axillary artery.When the 8fr shuttle sheath was inserted into the axillary artery, the sheath separated over the wire from the white hub at the proximal end.The sheath had to be removed and a second 8fr sheath was opened and used for the remainder of 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.

• 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: 5488754
• Report Number: 1820334-2016-00125
• Device Sequence Number: 11036880
• Product Code: DYB
• UDI-Device Identifier: 00827002128361
• UDI-Public: (01)00827002128361(17)160901(10)4506413
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2016

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: KSAW-8.0-38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2016
• Device Age: 29 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR