MAUDE Adverse Event Report: COOK INC ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G09535
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510k # k182985.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, a strand of hair was found within the primary packaging of a roadrunner the firm lt hydrophilic wire guide.The product was being inspected by the user facility when it was received, what the foreign matter was found.The device did not make patient contact.
Event or Problem Description
No new event information since the last report was submitted.
Additional Manufacturer Narrative
Event summary: as reported, a strand of hair was found within the primary packaging of a roadrunner the firm lt hydrophilic wire guide.The product was being inspected by the user facility when it was received, what the foreign matter was found.The device did not make patient contact.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, instructions for use (ifu), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did not return the complaint device for evaluation.However, there were photos provided.The photos show a long hair sealed in the packaging.In response to this incident, cook reviewed the device history record.The dhr for lot the complaint device lot records one non-conformance for foreign matter, reworked seven.A database search for complaints on the reported lot found no additional complaints reported from the field.Although there has been a total of one lot related complaint for this failure mode, there is 100% inspections to capture this failure mode prior to distribution and there is objective evidence that the dhr was fully executed.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded manufacturing/quality control deficiency contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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: ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, 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 ; 8128294891
• MDR Report Key: 12770216
• Report Number: 1820334-2021-02452
• Device Sequence Number: 4326066
• Product Code: DQX
• UDI-Device Identifier: 00827002095359
• UDI-Public: (01)00827002095359(17)240313(10)13696975
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Device Expiration Date: 03/13/2024
• Device Model Number: G09535
• Device Catalogue Number: RLPC-35-260
• Device Lot Number: 13696975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• 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