MAUDE Adverse Event Report: COOK INC APPROACH HYDRO ST MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G52939
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 interventional procedure involving a calcified right peroneal artery, the tip of an approach hydro st microwire wire guide separated in the patient.The physician reportedly altered the wire prior to use, putting a slight angle on the wire.Access was obtained in right common femoral artery.A cook 6-french, 45-centimeter ansel sheath was used during the procedure, as well as a cook 0.018-inch cxi catheter.The chronic total occlusion within the peroneal artery was crossed.When the user attempted to pull the cxi catheter out, the tip of the wire ¿sheared off¿.Per the reporter, the wire was not pulled or manipulated backwards through a needle or other metal instrument during the procedure.A new wire was placed.The user did not attempt to retrieve the separated wire tip, which remains in the right peroneal artery.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Corrected/additional information: d4, d9, h3.H3: device evaluation has begun; however, a conclusion is not yet available.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an interventional procedure involving a calcified right peroneal artery, the tip of an approach hydro st microwire wire guide separated in the patient.The physician reportedly altered the wire prior to use, putting a slight angle on the wire.Access was obtained in right common femoral artery.A cook 6-french, 45-centimeter ansel sheath was used during the procedure, as well as a cook 0.018-inch cxi catheter.The chronic total occlusion within the peroneal artery was crossed.When the user attempted to pull the cxi catheter out, the tip of the wire ¿sheared off¿.Per the reporter, the wire was not pulled or manipulated backwards through a needle or other metal instrument during the procedure.A new wire was placed.The user did not attempt to retrieve the separated wire tip, which remains in the right peroneal artery.The patient did not require any additional procedures or experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The wire was elongated and the distal tip of the wire was missing.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no discrepancies or additional relevant complaints on the final or sub-assembly lots.The product ifu notes that torquing against resistance may cause vessel trauma or wire damage, which may lead to device fracture.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 device 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 although a definitive cause for the event could not be determined, it is possible that the patient¿s anatomy/condition and the nature of the procedure contributed to the event.The lesion was calcified and totally occluded.The physician applied a slight angle to the wire prior to use; however, the specific technique used to shape the wire is unknown.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: APPROACH HYDRO ST MICROWIRE 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: 23312333
• Report Number: 1820334-2025-01262
• Device Sequence Number: 14699580
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)270824(10)16692788
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091385
• 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,Followup
• Report Date (Section B): 02/19/2026

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: G52939
• Device Catalogue Number: HMW-14-300-ST
• Device Lot Number: 16692788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 02/02/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/28/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG