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

Model Number	G27023
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: supply analyst.Pma/510(k) #: k171999.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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
As reported, the dilator of a performer introducer, would not advance into the sheath more than a few inches without extreme force.The issue was discovered while they were prepping the device for an unspecified procedure and the device was not used.Another same type device was used with no problems.Upon inspection of the returned device it was discovered that the silicon disc (valve) was not in the correct position.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 has been received since the last report was submitted.
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
Summary of event: as reported, the dilator of a performer introducer would not advance into the sheath more than a few inches without extreme force.The issue was discovered while they were prepping the device for an unspecified procedure and the device was not used.Another same-type device was used with no problems.Upon inspection of the returned device, it was discovered that the silicone disc (valve) was not in the correct position.No adverse events have been reported as a result of the alleged malfunction.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.The dilator could not be inserted into the sheath, and the silicone disc was dislodged.The hub was disassembled to remove the disc to check for damage and was then re-installed.With the disc put back in place, the dilator advanced through the sheath without difficulty.No additional damage was noted to the device components.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant non-conformance was noted on a subassembly lot; however, affected product was scrapped, and there are 100% inspections in place to capture this non-conformance prior to distribution.A supplier investigation was conducted.The supplier concluded that all components were manufactured to specification.The product ifu cautions ¿the maximum diameter of the instrument or catheter to be introduced should be determined to ensure that it will pass through the introducer¿ all instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight¿ when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position¿ before removing or inserting devices through the introducer, aspirate through the side-arm of the valve to clear the introducer, then flush with heparinized saline.¿ the ifu instructs the user to inspect the product upon removal from the package to ensure no damage has occurred.The information provided upon review of the dmr, dhr, ifu, supplier investigation, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure unrelated to the design or manufacturing of the device contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15165464
• Report Number: 1820334-2022-01310
• Device Sequence Number: 17326012
• Product Code: DYB
• UDI-Device Identifier: 00827002270237
• UDI-Public: (01)00827002270237(17)250517(10)14737446
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2023

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: 05/17/2025
• Device Model Number: G27023
• Device Catalogue Number: RCFW-16.0P-38-35-RB
• Device Lot Number: 14737446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 01/05/2023
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 08/30/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown