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

Model Number	G11672
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, particles were observed in the sterile and unopened packaging of a performer introducer.The particles were noted on the "hub of grey introducer." a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(6).Occupation: imaging manager, radiology department.Pma/510k #: k171999.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Summary of event: as reported, particles were observed in the sterile and unopened packaging of a performer introducer.The particles were noted on the "hub of grey introducer." a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.An inspection of the returned, unused product was also conducted.The complainant returned one sealed, unopened performer introducer to cook for investigation.White particle were noted on the grey hub.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A device master record review was performed, including device manufacturing instructions and quality control document.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the product labeling.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: how supplied ¿supplied sterilized by ethylene oxide gas in peel-open packages.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ cook has concluded manufacturing/quality control deficiency contributed to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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 new patient or event information to report since the previous medwatch was submitted.

• 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: 12813841
• Report Number: 1820334-2021-02497
• Device Sequence Number: 5575225
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)231209(10)13509327
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022

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: 12/09/2023
• Device Model Number: G11672
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Device Lot Number: 13509327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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