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

Model Number	G30492
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: director of operations.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, prior to an unknown procedure the coating of a roadrunner uniglide hydrophilic wire guide was found to be coming off.The user had prepared the device as per the ifu and beginning to insert the device when it was found that the coating of the device was coming off.The device was then placed back into its packaging.It is unknown how the procedure was completed.No portion of the device was left inside the patient.This did not require additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.Additional information has been requested.
Additional Manufacturer Narrative
D11: concomitant products= terumo "hidro" wire, terumo 5fr introducer, and terumo diagnostic catheter.Corrected information: d2: common name & product code = dqx wire, guide, catheter; dqx.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 or Problem Description
Additional information was received 30sep2020.Right femoral access was obtained for the diagnostic procedure.The anatomy was reportedly calcified.The wire was not altered prior to use and the device did not kink.Latex surgical gloves were worn during the procedure.The hydrophilic coating was activated with an unknown solution to ¿purge¿ the device for at least ten minutes and the device was kept in a tray with the solution prior to use.The device was used only one time.The wire reportedly ¿lost¿ the hydrophilic coating and flaking was reported.
Additional Manufacturer Narrative
Description of event: as reported, prior to an unknown procedure the coating of a roadrunner uniglide hydrophilic wire guide was found to be coming off.Right femoral access was obtained for the diagnostic procedure.The anatomy was reportedly calcified.The wire was not altered prior to use and the device did not kink.Latex surgical gloves were worn during the procedure.The hydrophilic coating was activated with an unknown solution to ¿purge¿ the device for at least ten minutes and the device was kept in a tray with the solution prior to use.The device was used only one time.The wire reportedly ¿lost¿ the hydrophilic coating and flaking was reported.The user had prepared the device as per the ifu and beginning to insert the device when it was found that the coating of the device was coming off.The device was then placed back into its packaging.It is unknown how the procedure was completed.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one hpwa-35-260 prior to use to cook for investigation.Physical examination of the returned device showed: one opened wire received.Inspection found the polymer jacket has been sheared off exposing wire starting at 3mm from distal end and having a length14.5cm.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions avoid manipulating or withdrawing the hydrophilic wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel.How supplied: store in a dark, dry, cool place.Avoid extended exposure to light upon removal from package, inspect the product to ensure no damage has occurred.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the provided evidence, completed supplier investigation, and the completed investigation by cook, it has been concluded a device failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 or Problem Description
No new patient or event information to report.

• Brand Name: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10528018
• Report Number: 1820334-2020-01675
• Device Sequence Number: 2738275
• Product Code: DQX
• UDI-Device Identifier: 00827002304925
• UDI-Public: (01)00827002304925(17)221203(10)10168134
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: G30492
• Device Catalogue Number: HPWA-35-260
• Device Lot Number: 10168134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 02/16/2021
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/01/2020; 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1