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

Catalog Number	HPWS-35-260
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer name and address = address: (b)(6).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
As reported, while preparing for an unknown procedure, the sterile barrier of a roadrunner uniglide hydrophilic wire guide's package was found to be damaged/compromised.The device did not make patient contact.Another device of the same type was used to complete the procedure.There were no adverse effects to the patient.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Summary of event: as reported, while preparing for an unknown procedure, the sterile barrier of a roadrunner uniglide hydrophilic wire guide's package was found to be damaged/compromised.The device did not make patient contact.Another device of the same type was used to complete the procedure.There were no adverse effects to the patient.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.A visual inspection of unused product was also conducted.The complaint device was returned to cook for investigation.The left side pouch seal was missing.Adhesive residue was not noted.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number or any final lot using the same package raw material.The pouch is supplied to cook from an external supplier; therefore, a supplier investigation was conducted.Although no manufacturing anomalies were noted on the lot, the supplier could not identify a root cause at this time.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, and investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, there is no evidence of additional non-conforming product in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing and quality control deficiency contributed to this event.Cook has concluded that this is an isolated incident, and no additional escalation is needed at this time.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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.

• 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: 17756464
• Report Number: 1820334-2023-01244
• Device Sequence Number: 12515251
• Product Code: DQX
• UDI-Device Identifier: 00827002304963
• UDI-Public: (01)00827002304963(17)240727(10)14083717
• Combination Product (Y/N): N
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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 Expiration Date: 07/27/2024
• Device Catalogue Number: HPWS-35-260
• Device Lot Number: 14083717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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