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

Catalog Number	RCFW-18.0P-38-30-RB
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, prior to use during an unknown procedure, a performer introducer was opened and it did not have a "valve".The device did not make patient contact.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Upon return and initial evaluation of the complaint device, the silicone disc was missing.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) # - k171999.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: h6 annex g.Summary of event: as reported, prior to use during an unknown procedure, a performer introducer was opened, and it did not have a "valve".The device did not make patient contact.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Upon return and initial evaluation of the complaint device, the silicone disc was missing.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A dimensional verification, functional test, and visual inspection were conducted as well.The complaint device was returned to cook for investigation.The silicone disc was in fact present, but it was pushed down into the sheath shaft.The silicone disc was removed by cutting down the shaft and then examined.The slits were in the center and appeared to be the correct depth.The dilator was reinserted into the sheath to check compatibility, and it passed through the sheath with no difficulty.The disc was reinserted into the cap and reinstalled on the hub, and the dilator passed through again without dislodging when inserting with the correct technique.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot and sub assembly lots.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿all instruments of 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.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, returned device, and complaint file 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.Based on the information provided and the results of the investigation, cook believes that issues during preparation for the procedure likely caused the disc to become dislodged.The most likely possibility is that the disc was dislodged by inserting the dilator off-center, and then when the customer removed the dilator, they discovered the disc was not in the hub.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: 19050310
• Report Number: 1820334-2024-00473
• Device Sequence Number: 8565919
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)260406(10)15376704
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/10/2024

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: 04/06/2026
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 15376704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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