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

Model Number	G11672
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: medtronic evolut r valves, performer introducer, lot# 8403745.Pma/510(k) number: pre-amendment.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a transcatheter aortic valve implantation (tavi) procedure, the valve of a performer introducer leaked blood (refer to this report).A second performer introducer, from a different lot (refer to medwatch 1820334-2018-01885) was then used with the same result.The procedure was able to be successfully completed with the second device despite the blood leakage.The complainant was not able to quantify the amount of blood that leaked; however, no adverse effect has been reported due to this occurrence, and no additional procedures were required.Other product used with the complaint device includes another manufacturer's aortic valve.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and a visual inspection and functional evaluation of the returned devices were conducted during the investigation.The visual inspection of the returned device confirmed that the check-flo disk was torn on one side.The cause of the tear could not be determined.Leak testing was also performed, and the leak could not be reproduced; however, it is possible that the leak may have partially re-healed prior to failure analysis, resulting in an inability to duplicate the failure mode.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 one nonconforming event which may be related to the failure mode; however, due to the individual nature of the product manufacturing and 100% verification of manufacturing specifications in final quality control prior to shipping, there is no indication that there is nonconforming product in the field.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to investigation findings.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7650133
• Report Number: 1820334-2018-01884
• Device Sequence Number: 2435267
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)201215(10)8390604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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 Expiration Date: 12/15/2020
• Device Model Number: G11672
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 8390604
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1