MAUDE Adverse Event Report: CORDIS CORPORATION TEMPO AQUA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 452507H0

Device Problems Burst Container or Vessel (1074); Crack (1135)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

As reported, there was a sudden rupture of a 5f a1 100cm tempo aqua multipurpose (mp) adult catheter during the exam.There were no reports of patient injury.The device will be returned for evaluation.

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there was a sudden rupture of a 5f a1 100cm tempo aqua multipurpose (mp) adult catheter during the exam.There were no reports of patient injury.The device was returned for evaluation.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, there was a sudden rupture of a 5f a1 100cm tempo aqua multipurpose (mp) adult catheter during the exam.There were no reports of patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17992700 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device, the limited information provided, and no images provided, the reported ¿ruptured¿ could not be confirmed or further clarified.Procedural factors such as difficulty advancing over a wire do to resistance either from device interaction, vascular anatomy or insufficient flushing of the catheter.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, ¿forcibly aspirate and flush the catheter at least once every two minutes.Ptfe coated guidewires are recommended for use with cordis angiographic catheters.¿ 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 preventative or corrective actions will be taken at this time.

Manufacturer Narrative

As reported, there was a sudden rupture of a 5f a1 100cm tempo aqua multipurpose (mp) adult catheter during the exam.There were no reports of patient injury.A unit of catheter cath tempo aqua 5f mp a1 100cm was received for analysis.During visual inspection, abnormal coloration was noted on the catheter.Additionally, several cracks were noted on the body of the catheter.Dimensional and functional analysis could not be performed due to the condition of the returned device.Ftir and dsc analysis was performed to the catheter and found photodegradation on the catheter material.Microscopic analysis was not performed because the cracks on the catheter were caused by the photodegradation of the material.A product history record (phr) review of lot 17992700 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft)- burst¿ was not confirmed because this condition was not observed.However, the malfunction ¿catheter (body/shaft)- cracked¿ was confirmed.The catheter presented with photodegradation which means it was subjected to high temperatures, which led to the cracks.Shipping/handling factors may have contributed to the reported event.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, ¿store in a cool, dark, dry place.Exposure to temperatures above 54o c (130° f) may damage the catheter.¿ 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 preventative or corrective actions will be taken at this time.

Event Description

As reported, there was a sudden rupture of a 5f a1 100cm tempo aqua multipurpose (mp) adult catheter during the exam.There were no reports of patient injury.The device was returned for evaluation.

• Brand Name: TEMPO AQUA
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua, FL 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 16554126
• MDR Text Key: 311679256
• Report Number: 9616099-2023-06352
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 452507H0
• Device Catalogue Number: 452507H0
• Device Lot Number: 17992700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• 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 Ethnicity: Non Hispanic