MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451415V0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a patient was undergoing an endovascular procedure for right leg stenosis.During treatment, the radiopaque tip of the 4f tempo berenstein ii (bern 2) diagnostic catheter broke off inside the patient's artery.The surgeon realized this immediately.Small vascular balloons were inserted and inflated distal to the foreign body, and 'dragged' the tip into the sheath.The patient was given heparin reversal.All devices (including the foreign body) were then removed from the patient and pressure held to artery for twenty (20) minutes.No further treatment could be given to the patient at this time due to the incident.Patient will require a return to theatre for original treatment.Device pictures were received for review.

Event Description

As reported, a patient was undergoing an endovascular procedure for right leg stenosis.During treatment, the radiopaque tip of the 4f tempo berenstein ii (bern 2) diagnostic catheter broke off inside the patient's artery.The tip of catheter separated from the body of the catheter and balloon was required to remove the tip.The surgeon realized this immediately.Small vascular balloons were inserted and inflated distal to the foreign body, and 'dragged' the tip into the sheath.The patient was given heparin reversal.All devices (including the foreign body) were then removed from the patient and pressure held to artery for twenty (20) minutes.No further treatment could be given to the patient at this time due to the incident.The procedure had to be cancelled and the patient will return to re-attempt the original procedure to treat right leg stenosis.The device was not used for a chronic total occlusion (cto).There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The tip was visible on fluoroscopy throughout the procedure.A procedural cd is not available.The device was not returned for evaluation; instead, three (3) pictures related to the reported failure were attached were provided for review.The first picture a separated brite tip with an unknown catheter balloon inserted can be observed.In the second picture, a diagnostic 4f catheter and a separated brite tip is shown.The third picture presents only the brite tip separated.No other outstanding details could be observed.The complaint reported by the customer as ¿brite tip/distal tip-separated" was confirmed according to pictures reviewed.

Manufacturer Narrative

As reported, a patient was undergoing an endovascular procedure for right leg stenosis.During treatment, the radiopaque tip of the 4f tempo berenstein ii (bern 2) diagnostic catheter broke off inside the patient's artery.The tip of catheter separated from the body of the catheter and balloon was required to remove the tip.The surgeon realized this immediately.Small vascular balloons were inserted and inflated distal to the foreign body, and 'dragged' the tip into the sheath.The patient was given heparin reversal.All devices (including the foreign body) were then removed from the patient and pressure held to artery for 20 minutes.No further treatment could be given to the patient at this time due to the incident.The procedure had to be cancelled and the patient will return to re-attempt the original procedure to treat right leg stenosis.The device was not used for a chronic total occlusion (cto).There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The tip was visible on fluoroscopy throughout the procedure.The device was not returned for evaluation however, three images were provided for review.In the first picture, an unknown balloon catheter inserted through a separated brite tip (radiopaque distal tip) is observed.In the second picture, a 4 french diagnostic catheter and a separated brite tip is shown.The third picture shows a separated brite tip.The reported ¿brite tip/distal tip-separated¿ was confirmed by photo analysis.A separation of the brite tip was observed.However, it is not possible to establish whether the separation is related to the manufacturing process of the product based on the image review.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

• Brand Name: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18124539
• MDR Text Key: 327963982
• Report Number: 9616099-2023-06630
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007870
• UDI-Public: 10705032007870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 451415V0
• Device Lot Number: 18192723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2023
• 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
• Treatment: UNK SHEATH.; UNK SMALL VASCULAR BALLOONS.
• Patient Outcome(s): Required Intervention