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

Catalog Number HPWA-35-180

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Customer name and address = phone: (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 a percutaneous transluminal angioplasty, the hydrophilic coating peeled off of a roadrunner uniglide hydrophilic wire guide as an unknown catheter was exchanged over the wire.Reportedly, the debris from the coating would block the tip of the catheter and the user felt "uncomfortable".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.

Manufacturer Narrative

Additional information: b5.H3: device evaluated by mfg.Other (81) - device evaluation has begun; however, a conclusion is not yet available.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 18jun2020.As reported, the user was unable to visually identify which part of coating was peeling from the catheter.The wire reportedly became stuck in the catheter tip.

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 a percutaneous transluminal angioplasty, the hydrophilic coating peeled off of a roadrunner uniglide hydrophilic wire guide as an unknown catheter was exchanged over the wire.Reportedly, the debris from the coating would block the tip of the catheter and the user felt "uncomfortable".Additional information received 18jun2020.As reported, the user was unable to visually identify which part of coating was peeling from the catheter.The wire reportedly became stuck in the catheter tip.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 instructions for use (ifu), quality control, and specifications was conducted during the investigation.A functional test of the returned complaint device was also conducted.The complaint device was wet and slick when returned.There was no damage noted to the coating or the polymer jacket on the wire.No issues were noted during the analysis.A document-based investigation evaluation was performed.As the lot number was unknown, a device history record review was not possible.Cook reviewed the hydrophilic coating manufacturing instructions and quality control checks in place to identify this failure mode.Cook has confirmed that there are sufficient inspection activities to ensure that wire guides are adequately coated prior to packaging.There was objective evidence that the device was manufactured to specification.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.There were no issues noted with the device during the lab analysis.It is possible that the catheters used during the case may have contributed to the resistance noted; however, this cannot be confirmed.The risk analysis for this failure mode was reviewed and no additional 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.

Event Description

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

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
• MDR Report Key: 9799586
• MDR Text Key: 182921645
• Report Number: 1820334-2020-00561
• 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: company representative,foreig
• 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 Catalogue Number: HPWA-35-180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 06/18/2020; 08/10/2020; 05/05/2021
• Supplement Dates FDA Received: 07/10/2020; 08/21/2020; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1