MAUDE Adverse Event Report: COOK INC SAFE-T-J ROSEN HEAVY DUTY WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx, not dxq.Occupation: manager.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.
Event or Problem Description
It was reported a safe-t-j rosen heavy duty wire guide malfunctioned during an unknown procedure.It was noted that "the patient is okay, but they were concerned about fragments of the wire being left behind." the exact nature of the wire guide malfunction is currently unknown.Additional information regarding event and device details have been requested, but are unavailable at this time.
Event or Problem Description
In additional information received on (b)(6) 2021, it was reported that the wire unraveled while inside of the drain as the wire and plastic inner dilator were removed simultaneously.There was no resistance when the drain catheter was advanced over the guidewire.No piece or fragment of the wire remained in the patient.When it was seen that the wire was stretching, everything was taken out together (drain catheter, dilator within the drain catheter, and wire within the lumen of the inner dilator).There was a delay in the procedure, as another puncture of the abscess was needed.The patient was exposed to additional radiation, as it was a ct guided procedure.No additional adverse effects were experienced by the patient.No kink in the wire was observed.The wire was not being removed through a needle or other instrument.It was being removed in unison with the plastic dilator.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5.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
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: d9 - product received on.Correction: d2a, d2b, h6 - annex f investigation ¿ evaluation texas children¿s hospital the woodlands, in the united states, informed cook on (b)(6) 2021 of an incident involving a safe-t-j rosen heavy duty wire guide, rpn: thscf-35-80-1.5-rosen from lot# 13505367.The complainant reported that the wire unraveled while inside the drain when removed simultaneously and were concerned about wire fragments left behind in the patient on (b)(6) 2021.Further communication with the user facility clarified that there was no resistance when drain was advanced over the wire, no fragments remained in the patient, there was no kink in the wire, no adverse events and the wire was not removed through a needle or other instrument.The patient reportedly experienced no adverse effects as a result of this incident.A review of the documentation including the complaint history, device history record (dhr), instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.A ult drainage device, flexible stiffener and a safe-t-j rosen heavy duty wire guide were returned for evaluation.The wire was found to be through the lumen of the blue flexible stiffener and lodged in the lumen of the ult device.Wire separation of the weld connection at the ¿j¿ curve resulting in coil elongation, as well as safety and mandril wire protrusion, was confirmed.The distal weld connection remained intact.Although the wire guide was damaged, it appeared that no material was missing.The catheter and flexible stiffener were undamaged and continued to function properly.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) demonstrated that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 13505367 found related nonconformances in which one device was scrapped for a large weld, two devices were scrapped for a broken wire and another four were scrapped for an incorrect curve.It should be noted that there were no other complaints associated with this lot number.As 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 nonconforming product exists in house or in field.The instructions for use (ifu) provides the following information related to the reported failure mode: precautions ¿do not attempt to torque wire guide.When you use the wire guide with another device, consider the end-hole size and length of the device in order to ensure proper fit between the wire guide and the device.¿ based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiency contributed to the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: SAFE-T-J ROSEN HEAVY DUTY 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: 11569250
• Report Number: 1820334-2021-01010
• Device Sequence Number: 11627914
• Product Code: DQX
• UDI-Device Identifier: 00827002017740
• UDI-Public: (01)00827002017740(17)251104(10)13505367
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022
• 2 Devices were Involved in the Event: 1 2

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: 11/04/2025
• Device Model Number: N/A
• Device Catalogue Number: THSCF-35-80-1.5-ROSEN
• Device Lot Number: 13505367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 12/22/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/19/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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