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 Type  malfunction  

Event Description

As originally reported, during an unknown procedure(s), four roadrunner uniglide hydrophilic wire guides were "sticky and tacky", even when kept wet in a basin of sterile water when not in use.The wires were attempted to be advanced through a cook catheter; however, resistance was felt and the wires became "impossible to pass".Upon removal of the wires, 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 these wires.The wires were removed, and a competitor's wire was used for the procedure(s).A section of the device did not remain inside any patient's body.The patient(s) did not experience any adverse effects or require any additional procedures due to these occurrences.Additional information was received 11mar2024, stating that "clear gelatinous and sometimes powdery" material flaked from the wires; however, the metal was not exposed.Both latex and powdered gloves were worn, and the coating was initially activated with heparinized saline.The wires were used immediately after activation and were used one time.

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.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 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: 19042119
• MDR Text Key: 339443232
• Report Number: 1820334-2024-00464
• 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