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

Model Number	G28322
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a procedure, the valves of two performer introducer sheaths (from the same lot number) caused large amounts of leakage.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 has been requested, but is not available at this time.
Additional Manufacturer Narrative
Additional information: it was later clarified by the customer in a response to a request for additional information that the valves were not tight, causing blood to leak.The patient was stated to be unharmed and no intervention was required as a result of this event.Corrected information: device was received on 27dec2017 and was available at the time that the initial medwatch report was submitted.Device evaluation in progress, but not yet complete.This event is currently under investigation.A supplemental report will be provided upon conclusion.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device noted small indents on both sheaths; however, there was no visible damage to the check-flo bodies, and the internal diameters of the connector caps and check-flo bodies were within specification.When subjected to a water pressure test, one sheath leaked water and one did not.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.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: 7154438
• Report Number: 1820334-2017-04570
• Device Sequence Number: 19329868
• Product Code: DYB
• UDI-Device Identifier: 00827002283220
• UDI-Public: (01)00827002283220(17)201108(10)8309556
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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: G28322
• Device Catalogue Number: RCF-16.0-38-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 04/05/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/10/2018; 04/26/2018
• Patient Sequence Number: 1