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

Catalog Number HPWA-35-150

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

As reported, during an unknown procedure, a roadrunner uniglide hydrophilic wire guide became stuck in an unspecified catheter.Per the reporter, the physician believed that there was a problem with the hydrophilic coating and the reporter stated "in addition, we could check the debris of polymers." 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 to clarify the event details has been requested, but not yet received.

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 Description

Additional information was received 30jan2023.Another manufacturer's device was used to successfully complete the procedure.The access site was the common femoral artery.The patient did not have tortuous, calcified, or scarred anatomy.The wire was not altered from its original condition prior to use and the wire was kept hydrated while not in use.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.

Manufacturer Narrative

Additional information: b5, d9, h3: (other): the 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 Description

Upon return of the complaint device, the wire guide coating was separated, exposing the inner core wire.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, a roadrunner uniglide hydrophilic wire guide became stuck in an unspecified catheter.Per the reporter, the physician believed that there was a problem with the hydrophilic coating and the reporter stated "in addition, we could check the debris of polymers".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 30jan2023.Another manufacturer's device was used to successfully complete the procedure.The access site was the common femoral artery.The patient did not have tortuous, calcified, or scarred anatomy.The wire was not altered from its original condition prior to use and the wire was kept hydrated while not in use.Upon return of the complaint device, the wire guide coating was separated, exposing the inner core wire.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The used complaint device was returned to cook for investigation.A four centimeter section of the wire was exposed 68 centimeters from the distal tip.The missing four centimeters of the polymer jacket was returned separated from the wire guide.A test of the coating on the remaining covered section of the wire guide was tested and found to be lubricous.Cook was unable to review the device history record and complaint history due to a lack of lot information from the user facility.There is no evidence of nonconforming material in house or in the field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: preparation 1.Before removing the hydrophilic wire guide from its dispenser, inject sterile heparinized saline solution into the luer lock hub of the dispenser.2.Inject enough solution to fill the dispenser coil.This will completely cover the wire guide surface and activate the hydrophilic coating.3.Remove the hydrophilic wire guide from its dispenser by gently withdrawing the wire¿s tip.4.If the hydrophilic wire guide cannot be removed from its dispenser, inject more heparinized saline solution into the dispenser and then try again.Wire guide use 1.Fill catheter or other device with heparinized saline solution before and during use to ensure smooth movement of the hydrophilic wire guide within the device.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.From the information provided upon review of the customer testimony, dmr, ifu, and inspection of the returned device provide objective evidence to support that the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies 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.

• Brand Name: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
• Type of Device: 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: 16243854
• MDR Text Key: 309143249
• Report Number: 1820334-2023-00063
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: HPWA-35-150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 01/30/2023; 02/24/2023; 04/07/2023
• Supplement Dates FDA Received: 02/24/2023; 03/01/2023; 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1