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

Catalog Number UNKNOWN

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Brand name and udi #: = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, the hydrophilic coating was coming off the roadrunner uniglide hydrophilic wire guide and the customer had a hard time advancing it.Flaking was noted.The hydrophilic coating was reportedly peeling despite continued flushing and wiping off; it remained sticky.The coating had been activated using heparinized saline and heparinized flush and was kept hydrated when not in use.It is unknown how long the coating was activated or how many times the device was used.The unspecified procedure was able to be completed.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.Neither the lot nor the product number was provided, it was unknown.The device will not be returned to the manufacturer to aid in the investigation; it was discarded at the facility.However, videos were provided.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the manufacturer¿s instructions and quality control 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 is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The device is shipped with instruction for use (ifu) which notes the proper warnings, precautions, and preparation methods.There is no evidence that suggest the ifu instructions were not followed.Based on the information provided and no product returned, investigation has concluded that a root cause for this event 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.

• 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: 8426380
• MDR Text Key: 139185446
• Report Number: 1820334-2019-00613
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/16/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1