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

Model Number	G09608
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: access coordinator.Pma/510(k) number: k182985.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, during a thrombectomy, a roadrunner nimble hydrophilic wire guide was sticky and difficult to advance.The patient experienced excessive bleeding.Pressure was held and sutures were placed to manage the bleeding, which stopped.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a thrombectomy, a roadrunner nimble hydrophilic wire guide was sticky and difficult to advance.The patient experienced excessive bleeding.Pressure was held and sutures were placed to manage the bleeding, which stopped.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found.One additional complaint was found on this lot; however, the complaint was reported by the same user facility for the same failure mode.Although there has been a total of two lot related complaints for this failure mode, there is no suspected manufacturing cause of this failure.There are 100% inspections to capture this failure mode prior to distribution and there is objective evidence that the dhr was fully executed.The product ifu warns ¿always keep the surface of the wire guide wet during use for optimal results.¿ the information provided upon review of the dmr, dhr, and ifu 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.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure unrelated to manufacturing contributed to this incident.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 or Problem Description
No additional information has been received since the previous report was submitted.

• Brand Name: ROADRUNNER NIMBLE 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: 13367686
• Report Number: 1820334-2022-00125
• Device Sequence Number: 5304058
• Product Code: DQX
• UDI-Device Identifier: 00827002096080
• UDI-Public: (01)00827002096080(17)241006(10)14233583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2024
• Device Model Number: G09608
• Device Catalogue Number: RFSPC-35-180
• Device Lot Number: 14233583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown