MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G09691
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Refer to user facility medwatch report (b)(4).(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during ultrasound-guided access to the patient's bilateral common femoral arteries, the performer introducer sheath would not remain sealed and was leaking.The sheath was removed and replaced with another device.The catheter utilized during the event was injected bilaterally into the aorta, and percutaneous endovascular abdominal aortic aneurysm (aaa) repair with a modular bifurcated graft (two docking limbs) was performed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details, patient anatomy and outcome was requested, but is not available at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device noted no damage on the exterior of the sheath or dilator.The silicone disc appeared to be positioned correctly; however, a small tear was noticed in the silicone disc.An attempt was made to duplicate the failure by clamping the distal end of the sheath and hand-injecting room temperature tap water through the stopcock.The reported leak could not be reproduced.Additionally, a document based investigation evaluation was performed.A review of the device history record showed 2 nonconforming events which could contribute to this failure mode; however, all nonconforming devices were scrapped, replaced, and inspected prior to release.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7129214
• Report Number: 1820334-2017-04355
• Device Sequence Number: 19112303
• Product Code: DYB
• UDI-Device Identifier: 00827002096912
• UDI-Public: (01)00827002096912(17)200828(10)8123615
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: G09691
• Device Catalogue Number: RCFW-16.0P-38-30-RB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 86