MAUDE Adverse Event Report: COOK INC ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G07640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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, during an atherectomy procedure, the tip of a roadrunner extra-support bare mandril wire guide broke off inside of the patient.The wire was not altered prior to use.Antegrade femoral access was obtained for a contralateral approach.The arteries were reportedly calcified, and it was difficult to cross the lesion.Per the reporter, during atherectomy using another manufacturer¿s atherectomy device, the wire sheared off.The patient was taken to the operating room, and the wire was successfully removed from the patient.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this event.
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
Summary of event: as reported, during an atherectomy procedure, the tip of a roadrunner extra-support bare mandril wire guide broke off inside of the patient.The wire was not altered prior to use.Antegrade femoral access was obtained for a contralateral approach.The arteries were reportedly calcified, and it was difficult to cross the lesion.Per the reporter, during atherectomy using another manufacturer¿s atherectomy device, the wire sheared off.The patient was taken to the operating room, and the wire was successfully removed from the patient.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this event.Corrected information: d4 (udi).Investigation evaluation: reviews of the complaint history, device history record (dhr), 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.A review of the device history record and complaint history found no relevant discrepancies or additional relevant complaints on the lot.The product ifu states "upon removal from package, inspect the product to ensure no damage has occurred.¿ the ifu also states that the wire is a delicate instrument and should be handled carefully, and states that forceful angulation should be avoided.The safety and risk information for the rotarex rotational excisional atherectomy system warns ¿the rotarex family of catheters may only be used with the bd supplied guidewire with which they are packaged¿ (https://www.Bd.Com/en-us/products-and-solutions/products/product-families/rotarex-rotational-excisional-atherectomy-system, 2025).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 ifu suggests that there is evidence the device was manufactured to specification.Based on the information provided and the results of the investigation, cook has concluded that procedural issues and unintended use error contributed to this event.The anatomy was calcified and the lesion was difficult to cross.The safety and risk information for the rotarex atherectomy device warns that the device may only be used with the bd wire supplied with the atherectomy device.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 EXTRA-SUPPORT BARE MANDRIL 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: 22787227
• Report Number: 1820334-2025-00977
• Device Sequence Number: 18201997
• Product Code: DQX
• UDI-Device Identifier: 00827002076402
• UDI-Public: (01)00827002076402(17)300102(10)16403189
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 Model Number: G07640
• Device Catalogue Number: RSTF-18-300
• Device Lot Number: 16403189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BARD ROTAREX.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown