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

Model Number G56177

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Common name & product code:dqx wire, guide, catheter.Occupation: lead tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown number of procedures involving femoral access, the coating became sticky and has come off of an unknown number of roadrunner uniglide hydrophilic wire guides.Other manufacturer's devices, such as balloons, were reportedly used during the procedures.The wires were not altered prior to use and kinking was not noted.Powdered gloves were worn and the devices were hydrated with heparinized saline.Per the user, the wires would not activate appropriately.A section of the device did not remain inside any patient¿s body.The patients did not require any additional procedures due to this occurrence.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.

Event Description

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

Manufacturer Narrative

Initial report: as reported, during an unknown number of procedures involving femoral access, the coating became sticky and has come off of an unknown number of roadrunner uniglide hydrophilic wire guides.Other manufacturer's devices, such as balloons, were reportedly used during the procedures.The wires were not altered prior to use and kinking was not noted.Powdered gloves were worn and the devices were hydrated with heparinized saline.Per the user, the wires would not activate appropriately.A section of the device did not remain inside any patient¿s body.The patients did not require any additional procedures due to this occurrence.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.There was one failure related non-conformance recorded during the production of this lot, however these units were identified during cook¿s quality control checks and scrapped accordingly from the batch.There was one other complaint received on this lot, however it was reported from the same facility and user ((b)(4).).Given this information, the evidence indicates the product was made to specifications.No gaps were discovered in the quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device, which states ¿before removing the hydrophilic wire guide from its dispenser, inject sterile heparinized saline into the luer lock hub end of the dispenser inject enough solution to fill the dispenser coil.This will completely cover the wire guide surface and activate the hydrophilic coating remove the hydrophilic wire guide from it¿s dispenser by gently withdrawing the wire¿s tip if the hydrophilic wire guide cannot easily be removed from its dispenser, inject more heparinized saline solution into the dispenser and then try again.¿ based on the information provided and no product returned, investigation has concluded that a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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

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

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

• 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
• MDR Report Key: 9943164
• MDR Text Key: 200000947
• Report Number: 1820334-2020-00786
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002561779
• UDI-Public: (01)00827002561779(17)230106(10)10207194
• Combination Product (y/n): N
• PMA/PMN Number: K110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2021

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 Operator: Health Professional
• Device Model Number: G56177
• Device Catalogue Number: HPWAS-35-180
• Device Lot Number: 10207194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 08/10/2020; 05/05/2021
• Supplement Dates FDA Received: 08/19/2020; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1