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

Model Number	G06979
Medical Device Problem Codes	Difficult to Advance (2920); Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an angiography procedure, a roadrunner the firm hydrophilic wire guide was difficult to advance and "lost the hydrophilic condition" after the first use of the device.Difficult advancement was encountered during multiple "drives" with the device.Per the reporter, the physician noticed that the coating was rough prior to the procedure.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
Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k) number = k182985.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5 corrected information: h6 (annex g) summary of event: as reported, during an angiography procedure, a roadrunner the firm hydrophilic wire guide was difficult to advance and "lost the hydrophilic condition" after the first use of the device.Difficult advancement was encountered during multiple "drives" with the device.Per the reporter, the physician noticed that the coating was rough prior to the procedure.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 information was received 16nov2022.The event occurred during insertion of the device.The anatomy was not tortuous, calcified, or scarred.The wire was not altered prior to use.Powdered gloves were worn.The procedure was completed with another device.Per the physician, at a certain moment during the procedure, the wire did not slide or feel lubricated as it previously had felt.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.A supplier investigation was also performed.The supplier found no discrepancies in this lot or any other lot from this product line.The supplier could not identify a root cause for this failure.The product ifu instructs the user to activate the hydrophilic coating, stating ¿flush the wire guide holder by attaching or pressing a syringe with saline, heparinized saline solution, or sterile water to the fitting or opening of the wire guide holder.Inject enough solution to wet the wire surface entirely.This will activate the aq coating.¿ the ifu instructs the user to carefully remove the wire guide from the holder.The ifu states ¿note: an initial flush of heparinized saline solution through the catheter lumen will enhance initial movement of the wire guide through the catheter.¿ the information provided upon review of the complaint file, dmr, dhr, ifu, and supplier investigation 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 complaint device contributed to this incident.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.
Event or Problem Description
Additional information was received 16nov2022.The event occurred during insertion of the device.The anatomy was not tortuous, calcified, or scarred.The wire was not altered prior to use.Powdered gloves were worn.The procedure was completed with another device.Per the physician, at a certain moment during the procedure, the wire did not slide or feel lubricated as it previously had felt.

• Brand Name: ROADRUNNER THE FIRM 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 ; 8123392235
• MDR Report Key: 15248959
• Report Number: 1820334-2022-01357
• Device Sequence Number: 20285887
• Product Code: DQX
• UDI-Device Identifier: 00827002069794
• UDI-Public: (01)00827002069794(17)240930(10)14226481
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 09/30/2024
• Device Model Number: G06979
• Device Catalogue Number: RPC-35-145
• Device Lot Number: 14226481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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