MAUDE Adverse Event Report: COOK INC DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Model Number	G04035
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - customer (person): phone: (b)(6).E3- occupation: product specialist.Critical care ¿ surgisis.Lead management.G4- 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
It was reported that the wire guide included in the double lumen polyurethane central venous catheter set was difficult to remove during a central venous catheter installation procedure on a 3-month-old male patient.Central venous catheter installation into the right femoral vein was scheduled on (b)(6) 2024 due to poor peripheral access, the need for sedation and antibiotic treatment.Under aseptic and ultrasound-guided technique, a double lumen polyurethane central venous catheter was inserted into the targeted vessel.The vein was canalized, and the wire guide was advanced until a stop was felt.A decision was then made to withdraw the wire.Difficulty was experienced during attempted removal and an entrapment became evident.Once again, an attempt was made to remove the wire guide.It was then discovered that the wire guide had frayed, with only a portion being removed from the patient.Upon ultrasound evaluation of femoral vessels and extraluminal space by a vascular surgeon, the metal guide was found to be unraveled distally, with a knot in the tip.The guide was then pulled under ultrasound, but the guide was unable to be moved.Finally, together with a pediatric surgeon, the wire guide was partially removed, leaving a small 1cm portion in the muscular plane of the patient.Additional information regarding event details has been requested but is currently unavailable.No other adverse effects were reported for this incident.
Event or Problem Description
Additional information was received.It was confirmed that the wire guide was manipulated "only on the traditional way to perform the procedure".Ultrasound vision did not reveal any tortuous anatomy.The procedure was not completed; the central venous catheter (cvc) could not be installed.The portion of the device that remains in the patient will only be removed if it causes a problem for the patient.
Additional Manufacturer Narrative
Additional information: b5, d4 - model #.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 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 or that a death or serious injury occurred; nor is it admission 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
Correction: h6 - annex a.Investigation ¿ evaluation.It was reported that the wire guide included in the double lumen polyurethane central venous catheter set was difficult to remove during a central venous catheter installation procedure on a 3-month-old male patient.Central venous catheter installation into the right femoral vein was scheduled on (b)(6)2024 due to poor peripheral access, the need for sedation and antibiotic treatment.Under aseptic and ultrasound-guided technique, a double lumen polyurethane central venous catheter was inserted into the targeted vessel.The vein was canalized, and the wire guide was advanced until a stop was felt.A decision was then made to withdraw the wire.Difficulty was experienced during attempted removal and an entrapment became evident.Once again, an attempt was made to remove the wire guide.It was then discovered that the wire guide had frayed, with only a portion being removed from the patient.Upon ultrasound evaluation of femoral vessels and extraluminal space by a vascular surgeon, the metal guide was found to be unraveled distally, with a knot in the tip.The guide was then pulled under ultrasound, but the guide was unable to be moved.Finally, together with a pediatric surgeon, the wire guide was partially removed, leaving a small 1cm portion in the muscular plane of the patient.It was confirmed that the wire guide was manipulated "only on the traditional way to perform the procedure".Ultrasound vision did not reveal any tortuous anatomy.The procedure was not completed; the central venous catheter (cvc) could not be installed.The portion of the device that remains in the patient will only be removed if it causes a problem for the patient.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instruction for use (ifu) for device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, 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 device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: ¿instructions for use 4.Slide safe-t-j wire guide straightener (positioned on the distal tip of wire guide) over ¿j¿ portion of wire guide.Pass straightened wire guide through needle; advance wire guide 5-10 cm into vessel.If straight wire is used, always advance soft, flexible end through needle hub and into vessel.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.¿ evidence gathered upon review of dmr, product labeling, and dhr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It¿s possible the wire was damaged due to possible contact with the sharp edge of the needle during the manipulation of the wire guide.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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.

• Brand Name: DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• 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: 19724135
• Report Number: 1820334-2024-00939
• Device Sequence Number: 8148172
• Product Code: DQY
• UDI-Device Identifier: 00827002040359
• UDI-Public: (01)00827002040359(17)260419(10)15399072
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2026
• Device Model Number: G04035
• Device Catalogue Number: C-UDLM-401J
• Device Lot Number: 15399072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 03/19/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/08/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 3 MO
• Patient Sex: Male