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

Catalog Number HPWA-35-260

Device Problem Flaked (1246)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

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

As originally reported, during an unknown procedure, a roadrunner uniglide hydrophilic wire guide was "sticky and tacky", even when kept wet in a basin of sterile water when not in use.The wire was attempted to be advanced through a cook catheter, however, resistance was felt and the wire became "impossible to pass".Upon removal of the wire, the user was concerned that the coating would "shear off"; however, there was no report any shearing/separation of the coating.Per the reporter, the "sticky and tacky" feeling was felt with any device tracked over this wire.The wire was removed, and a competitor's wire was used for the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to the occurrence.Additional information was received 11mar2024, stating that "clear gelatinous and sometimes powdery" material flaked from the wire; however, the metal was not exposed.Both latex and powdered gloves were worn, and the coating was initially activated with heparinized saline.The wire was used immediately after activation and was used one time.

• 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: 19041921
• MDR Text Key: 339990659
• Report Number: 1820334-2024-00462
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002304925
• UDI-Public: (01)00827002304925(17)261024(10)15721427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPWA-35-260
• Device Lot Number: 15721427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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
• Treatment: .035 CXI