MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  Injury  

Manufacturer Narrative

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 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 Description

It was reported that the wire guide from a single lumen pressure monitoring set unraveled.During insertion of femoral arterial line, the wire unraveled.As a result, a cut-down surgery was required to remove the separate wire guide pieces.Additionally, surgical repair/graft of the vessel was performed.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 Description

Additional information was provided on 14aug2023.The procedure being completed was a diagnostic laparoscopy that was converted to an exploratory laparotomy to control splenic hemorrhage.The wire guide was placed in the common femoral artery.The wire became "knotted" when the catheter was advanced over it, and neither could be removed.The device malfunction required exploration and an arterial repair with ipsilateral saphenous vein graft.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex e.Investigation ¿ evaluation.(b)(6) medical center (usa) reported that on (b)(6) 2023, the wire guide from a single lumen pressure monitoring set (rpn: c-pms-500j; lot#: unknown) unraveled and separated.During insertion of femoral arterial line, the wire guide was placed in the common femoral artery.When the catheter was advanced over the wire, it became knotted, and neither component could be removed.The wire unraveled and separated.As result, a surgical cut-down was performed to remove the wire guide fragments.An arterial repair with ipsilateral saphenous vein graft was also required.No other adverse effects were reported for this incident.A review of documentation including the complaint history, instructions for use (ifu), and quality control procedures was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.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) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: "instructions for use: slide safe-t-j wire guide straightener) positioned on 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 guide 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.While maintaining wire guide position, withdraw needle and safe-t-j wire guide straightener.Enlarge puncture site with number 11 scalpel blade, if required.If dilation is required, dilator can be advanced over wire guide and removed prior to insertion of central venous catheter.Caution: to avoid vascular injury, do not use excessive force when advancing dilators.Use the smallest size dilator catheter placement will allow.Wire guide must always lead dilator by several centimeters.Do not advance dilator more than a few centimeters into the vessel.Measure catheter to be used against patient to determine approximate length of catheter needed from puncture site to central venous tip position.Introduce the central venous catheter over the wire guide.While maintaining wire guide position, advance catheter into vessel with a gentle twisting motion.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event has been traced to a component failure unrelated to manufacturing or design deficiencies.It is possible that excess force was placed on the device during the advancement of the catheter; however, this cannot be confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SINGLE LUMEN PRESSURE MONITORING SET
• Type of Device: 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: 17545609
• MDR Text Key: 321174165
• Report Number: 1820334-2023-01082
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-500J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 10/11/2023
• Supplement Dates FDA Received: 08/17/2023; 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White