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

Model Number	G06801
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: preamendment.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.
Event or Problem Description
As reported, during an endovascular therapy procedure, the user curved the tip of an amplatz extra-stiff support wire guide and the core wire was sticking out.The device did not make patient contact and an unspecified device was used to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.
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 endovascular therapy procedure, the user curved the tip of an amplatz extra-stiff support wire guide, and the core wire was sticking out.The device did not make patient contact and an unspecified device was used to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, quality control procedures, and a visual examination were conducted during the investigation.The complainant returned an amplatz extra-stiff support wire guide to cook for investigation.Physical examination of the complaint device revealed that the wire mandril was protruding through one of the coils and was bent at the point where it broke.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Cook reviewed the product labeling.The customer is not supplied with an ifu, and there are no materials provided to the customer relevant to this failure mode.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the device history record was fully executed, and no other related complaints from the lot that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents were conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the returned device evaluation, dmr, and dhr provides evidence that the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that contributing factors related to the procedure caused this incident.The user stated that they were manually curving the wire guide tip and that likely caused the damage to the wire during preparation.The risk analysis for this failure mode was reviewed and no additional escalation is 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: 16380594
• Report Number: 1820334-2023-00137
• Device Sequence Number: 6327137
• Product Code: DQX
• UDI-Device Identifier: 00827002068018
• UDI-Public: (01)00827002068018(17)270831(10)14935865
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: G06801
• Device Catalogue Number: THSF-35-145-AES-SGH
• Device Lot Number: 14935865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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