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

Model Number	G10678
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.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 a total of four performer introducers from this same lot leaked from the diaphragm on separate occasions.Reportedly, three events of leaking occurred during "arteriovenous fistula and or graft" thrombectomies.In these three events a 0.035 j-wire was in place inside the complaint device at the time.Estimated blood loss was described as "minimal".No medical intervention was required.The procedure was completed using a different device.Patient's outcome was described as "fine".The fourth leaking event occurred during testing of the performer introducer prior to patient contact.This report is for one performer introducer which leaked during the procedure.Please see the following medwatch reports for the three other events: 1820334-2018-03769; 1820334-2018-03770; 1820334-2018-03772.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.Investigation: a review of the dimensional verification functional test, complaint history, device history, manufacturing instructions, review of trends, visual inspection, and quality control were conducted during the investigation.The customer returned one rycfw-7.0-35-6-rb-cw device with the dilator.The dilator was not inserted into the device.There is no visible damage to the dilator.The introducer tubing is compressed just below the proximal fitting.The device has biological matter throughout.The tubing was occluded with hemostats and water was injected into the side arm to test for leakage.The device did not leak around the silicone disc.There is visible glue on the top of the fitting and around the threads, but no glue in the cap additionally, a document-based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The identified risk controls include manufacturing quality control checks and process validation.A review of the device history record for lot 9118563 did not show any related nonconformances and associated complaints for this lot.There is no evidence of nonconforming material in the field.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8173774
• Report Number: 1820334-2018-03771
• Device Sequence Number: 2142424
• Product Code: DYB
• UDI-Device Identifier: 00827002106789
• UDI-Public: (01)00827002106789(17)210824(10)9118563
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 08/24/2021
• Device Model Number: G10678
• Device Catalogue Number: RYCFW-7.0-35-6-RB-CW
• Device Lot Number: 9118563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1