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

Model Number	G28438
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
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, during a filter retrieval procedure on a patient of unknown age and gender, the performer introducer was used.As they were taking the dilator out before putting the snare in, it was noted that the one way valve had failed and blood was leaking from it.The cook representative confirmed it was a minimal amount of blood and no intervention was required.The physician removed the device in its entirety.Another of the same device was used to complete the procedure with no adverse effects.No harm to the patient and no additional procedures were required due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one rcfw-14.0-38-45-rb introducer sheath without the dilator was returned for investigation.There was biomatter present throughout the device.A kink was present at 22.2cm from the distal end of the hub, but this is presumed to be a result of how the device was packaged for return.The valve of the sheath appeared to be dislodged from its intended position but was present in the check-flo body.The device was flushed with water and it came out from both the proximal and distal ends.The sheath tubing was clamped using a hemostat and flushed again, and water again came out from the proximal hub.The proximal fittings were disassembled for further examination.The silicone disc appeared to be slit edge to edge, however during handling it was discovered that the slit on the bottom of the disc was only opened after the disc was pinched in the proper direction.With this information, the complaint can be confirmed.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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, labeling, quality control procedures, and the overall device history record were conducted, and no gaps were discovered.With these reviews cook has concluded that there are adequate controls in place to address this failure mode.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to component failure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8102553
• Report Number: 1820334-2018-03346
• Device Sequence Number: 1599357
• Product Code: DYB
• UDI-Device Identifier: 00827002284388
• UDI-Public: (01)00827002284388(17)210717(10)8983838
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/11/2019

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: 07/17/2021
• Device Model Number: G28438
• Device Catalogue Number: RCFW-14.0-38-45-RB
• Device Lot Number: 8983838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1