MAUDE Adverse Event Report: COOK INC SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G03565
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	01/26/2026
Type of Reportable Event	Death
Event or Problem Description
As reported to cook by another device manufacturer (abbott), during an unspecified procedure involving a patient with left atrial flutter, a safe-t-j amplatz extra-stiff support wire guide perforated the iliac vein during insertion of the wire.Upon insertion of an unknown sheath, the perforation reportedly enlarged.Per the reporter, a coronary angiogram was performed.The perforation resulted in bleeding.The patient died three days after the procedure.The physician stated that the wire was ¿too rigid¿ and the patient had fragile veins, which per the physician, caused the perforation.Per the other manufacturer, there were ¿no performance issues with the sheath¿.There has been no alleged malfunction of the cook wire guide.Additional information has been requested but is not available at this time.
Additional Manufacturer Narrative
D9, h3: it is unknown if the device will be returned.E1: phone = (b)(6) e4: reference number per abbott = (b)(4).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
Summary of event: as reported to cook by another device manufacturer (abbott), during an unspecified procedure involving a patient with left atrial flutter, a safe-t-j amplatz extra-stiff support wire guide perforated the iliac vein during insertion of the wire.Upon insertion of an unknown sheath, the perforation reportedly enlarged.Per the reporter, a coronary angiogram was performed.The perforation resulted in bleeding.The patient died three days after the procedure.The physician stated that the wire was ¿too rigid¿ and the patient had fragile veins, which per the physician, caused the perforation.Per the other manufacturer, there were ¿no performance issues with the sheath¿.There has been no alleged malfunction of the cook wire guide.Additional information was requested; however, a response was not received.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 ¿this product is a delicate instrument.Avoid forceful angulation.¿ the ifu cautions ¿do not attempt to torque the wire guide¿, ¿do not advance or manipulate the wire guide without visual evidence of the corresponding movement of the distal tip¿, and ¿do not advance or withdraw a wire guide when resistance is encountered, a perforation could occur.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to mitigate this type of event 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 the patient¿s anatomy and procedural issues related to device selection likely contributed to this event.Per the physician, the patient¿s veins were fragile, and the wire was ¿too rigid¿.It should be noted that the wire used was an extra-stiff amplatz, and ¿extra stiff¿ is noted in the device name.The risk analysis 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: SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT 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: 24481431
• Report Number: 1820334-2026-00228
• Device Sequence Number: 9360800
• Product Code: DQX
• UDI-Device Identifier: 00827002035652
• UDI-Public: (01)00827002035652(17)301230(10)16925935
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: G03565
• Device Catalogue Number: THSCF-35-180-3-AES
• Device Lot Number: 16925935
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown