MAUDE Adverse Event Report: COOK INC SAFE-T-J FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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.
Event or Problem Description
It was reported an unknown patient required a safe-t-j fixed core wire guide for insertion of a drain.The operator reported during insertion of the catheter, the "guidewire became stuck and was unable to be dislodged or removed from the drain." assistance was provided by a supervising consultant, but attempts were unsuccessful.It was reported the guidewire was "pulled and proceeded to disintegrate before removal." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that a safe-t-j fixed core wire became stuck and was unable to be dislodged or removed and the wire guide unraveled/disintegrated upon removal during a drain insertion procedure.This incident was reported by (b)(6) hospital, in australia.Further communication with the user facility clarified that the manufacturer and model number of the drain, insertion location of the drain and the date of event are unknown.No additional procedures were required due to this incident.No adverse effects were reported as a result of this incident.A review of the complaint history, device history record, manufacturing instructions, and quality control of the device were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Due to this no dimensional analysis or physical/visual inspection could be performed.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) was reviewed.The dhr for the lot recorded no relevant non-conformances.A data base search revealed no additional complaints for this lot from the field.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in the field.A review of product labeling could not be conducted as this device is not supplied with an instructions for use (ifu).Based on the information provided, no returned product, and results of the investigation, it was concluded that the main cause of the failure is due to component failure unrelated to manufacturing or design deficiencies.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.
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.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9592812
• Report Number: 1820334-2020-00124
• Device Sequence Number: 924103
• Product Code: DQX
• UDI-Device Identifier: 00827002005297
• UDI-Public: (01)00827002005297(17)240627(10)9824636
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

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: 06/27/2024
• Device Model Number: N/A
• Device Catalogue Number: TSCF-35-80-3
• Device Lot Number: 9824636
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 05/05/2021
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1