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

Model Number	G06801
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, prior to use of an amplatz extra-stiff support wire guide, the coil was unraveled.The wire guide was to be used for a drainage catheter placement.When the physician opened the package, they noticed that the coil of the wire guide was unraveled at approximately 3 cm from the tip.They used another device to complete the procedure.There have been no reported adverse effects to the patient.
Additional Manufacturer Narrative
Event summary: as reported, prior to use of an amplatz extra-stiff support wire guide, the coil was unraveled.The wire guide was to be used for a drainage catheter placement.When the physician opened the package, they noticed that the coil of the wire guide was unraveled at approximately 3 cm from the tip.They used another device to complete the procedure.There have been no reported adverse effects to the patient.Investigation - evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One amplatz extra-stiff support wire guide (thsf-35-145-aes-sgh) was returned for investigation in a prior-to-use, damaged state.The coil was protruding from the wire guide at the distal end approximately 3cm from the distal tip.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that shipping/handling contributed to this incident.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

• 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: 12583020
• Report Number: 1820334-2021-02285
• Device Sequence Number: 3289121
• Product Code: DQX
• UDI-Device Identifier: 00827002068018
• UDI-Public: (01)00827002068018(17)260716(10)14063174
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/08/2022

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 Expiration Date: 07/16/2026
• Device Model Number: G06801
• Device Catalogue Number: THSF-35-145-AES-SGH
• Device Lot Number: 14063174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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