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

Model Number	G03562
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon opening the packaging of a amplatz extra-stiff support wire guide, the wire was kinked and "drawing at the circular bend of the wire guide tip".The user did not attempt to shape the guidewire tip.A new device was used to complete the procedure.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.A photo provided by the customer shows possible mandril protrusion.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: name and address - postal code: 266000, phone: (b)(6) g4: pma/510(k) # - k171764.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.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.
Additional Manufacturer Narrative
Summary of event: as reported, upon opening the packaging of an amplatz extra-stiff support wire guide, the wire was kinked and "drawing at the circular bend of the wire guide tip".The user did not attempt to shape the guidewire tip.A new device was used to complete the procedure.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.A photo provided by the customer shows possible mandril protrusion.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.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The wire holder was not connected upon receipt of the device.The mandril of the wire protruded from the coils, approximately 4.1-centimeters from the distal tip.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The customer followed relevant instructions in the ifu (instructions for use).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.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that storage/transport contributed to this event.A photo provided by the customer shows that the wire holder was not connected, which could have occurred during shipping.Additionally, because the user did not attempt to shape the wire, it is likely that the damage occurred during transport of the device.One-hundred percent inspections are performed during production and packaging of the device; therefore, it is unlikely that the damage would have gone unnoticed prior to shipping.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: 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: 20543746
• Report Number: 1820334-2024-01410
• Device Sequence Number: 20639305
• Product Code: DQX
• UDI-Device Identifier: 00827002035621
• UDI-Public: (01)00827002035621(17)290320(10)15957676
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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 Model Number: G03562
• Device Catalogue Number: THSF-35-260-AES
• Device Lot Number: 15957676
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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