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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned.Common name & product code = dqx wire, guide, catheter.(b)(6).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 procedure, the coating of a roadrunner uniglide hydrophilic wire guide would not activate appropriately, became "sticky," and came off the wire.Additional information has been requested, but is unavailable at this 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 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 received 18mar2020.As reported, the coating came off of multiple devices during an unknown number of fistula revision procedures.The wire was not altered prior to use.The wire was hydrated with heparinized saline and handled with powdered gloves during use.No kinking was observed.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.

Event Description

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

Manufacturer Narrative

Summary of event: as reported, during an unknown procedure, the coating of a roadrunner uniglide hydrophilic wire guide would not activate appropriately, became "sticky," and came off the wire.Additional information received 18mar2020.As reported, the coating came off of multiple devices during an unknown number of fistula revision procedures.The wire was not altered prior to use.The wire was hydrated with heparinized saline and handled with powdered gloves during use.No kinking was observed.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.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned to cook for investigation; therefore, a device evaluation could not be conducted.A document-based investigation evaluation was performed.One failure-related non-conformance was found; however, all affected units were scrapped.One additional complaint was noted on the lot from the same user and facility.There is objective evidence that the device was most likely manufactured to specification.Cook also reviewed the manufacturing instructions and quality control procedures as they relate to the reported failure mode.Cook has confirmed that there are sufficient inspection activities to ensure that wire guides are adequately coated prior to packaging.The product ifu 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 its 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 the results of the investigation, cook has concluded that a definitive cause for this complaint could not be established.The risk analysis for this failure mode was reviewed and no 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.

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: 9843354
• MDR Text Key: 197131370
• Report Number: 1820334-2020-00630
• 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,user f
• Type of Report: Initial,Followup,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: 02/28/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/18/2020; 08/10/2020; 05/05/2021
• Supplement Dates FDA Received: 04/08/2020; 08/14/2020; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1