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

Catalog Number	HPWA-35-260
Medical Device Problem Codes	Flaked (1246); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an angiogram, the hydrophilic coating came off of a roadrunner uniglide hydrophilic wire guide.Access was obtained in the right groin to target the left superficial femoral artery.The anatomy was not tortuous, calcified, or scarred.The wire was not altered from its original condition prior to use.The coating was activated with saline, just prior to placing the wire in the patient.The wire was only used one time.Upon removal of the wire, black material flaked from the device.A new (unknown) wire was used to successfully complete the procedure.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = lead tech.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Corrected information: d9.H3, h6 (annex a) d9, h3: the complaint device will not be returned to cook.Summary of event: as reported, during an angiogram, the hydrophilic coating came off of a road runner uniglide hydrophilic wire guide.Access was obtained in the right groin to target the left superficial femoral artery.The anatomy was not tortuous, calcified, or scarred.The wire was not altered from its original condition prior to use.The coating was activated with saline, just prior to placing the wire in the patient.The wire was only used one time.Upon removal of the wire, black material flaked from the device.A new (unknown) wire was used to successfully complete the procedure.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: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection and functional test of unused products from the lot (returned by the customer) was also conducted.The complaint device was not returned to cook for investigation; however, two unused devices from the lot were returned from the customer.Both wire guides felt lubricious, and no damage was noted to the wires.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found one additional complaint for this lot number.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned unused devices from the same lot suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.The exact conditions experienced during the event cannot be duplicated.The anatomy was not tortuous, calcified, or scarred.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.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18841233
• Report Number: 1820334-2024-00296
• Device Sequence Number: 7294083
• Product Code: DQX
• UDI-Device Identifier: 00827002304925
• UDI-Public: (01)00827002304925(17)261024(10)15721424
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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 Catalogue Number: HPWA-35-260
• Device Lot Number: 15721424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown