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

Catalog Number SRD5559

Device Problem Burst Container or Vessel (1074)

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

Event Date 05/04/2023

Event Type  malfunction  

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, the proximal end of a 5f 125cm tempo aqua hydrophilic angiographic catheter was ruptured/broken after 5 minutes into an intervention.There were no reports of patient injury.A contralateral approach was not used.The target site vessel was severely tortuous.The device was not pulled from the packaging by the hub nor was it torqued or ¿steered¿ by the hub.There were no difficulties inserting, advancing, or withdrawing the device.The malfunction was discovered inside the patient.The procedure was a scheduled diagnostic interventional case.There was kinking within the aorta.The device was inserted through an unknown 6f guide catheter (gc) up to the aorta descendens.The device was turned and pushed, not much more than usual, and then the device broke.It appeared that the tip was ¿hooked¿ inside the truncus.Since the complaint product was still inside the guide catheter (gc) everything was removed step by step, without any harm to the patient.The complaint device and a sterile device will be 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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

-this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.-additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

-after further review of additional information received the following sections have been updated accordingly: as reported, the proximal end of a 5f 125cm tempo aqua hydrophilic angiographic catheter was ruptured/broken after 5 minutes into an intervention.There were no reports of patient injury.A contralateral approach was not used.The target site vessel was severely tortuous.The device was not pulled from the packaging by the hub nor was it torqued or ¿steered¿ by the hub.There were no difficulties inserting, advancing, or withdrawing the device.The malfunction was discovered inside the patient.The procedure was a scheduled diagnostic interventional case.There was kinking within the aorta.The device was inserted through an unknown 6f guide catheter (gc) up to the descending aorta.The device was turned and pushed, not much more than usual, and then the device broke.It appeared that the tip was ¿hooked¿ inside the truncus.Since the complaint product was still inside the guide catheter (gc) everything was removed step by step, without any harm to the patient.A non-sterile unit of ¿5f tempo 0.038 125cm ii¿ was received for analysis.During visual inspection, the unit was noted to be separated in two pieces.Both segments were returned.The separation is located approximately 85.5 cm from the distal tip.The unit presented with several kinks located approximately 12.5 cm from the proximal end.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was not performed because magnification obtained with the vision system was sufficient to observe the characteristics associated with the separation.Analysis with the vision system presented evidence of elongations and deformation on the plastic.Additionally, diameter reduction was observed on the braidewire.A product history record (phr) review of lot 18153106 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 as this condition was not observed.However, the complaint ¿catheter (body/shaft)-separated¿ was confirmed.The elongations, plastic deformations and diameter reduction observed at the separated edges are commonly caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to tensile/twist forces that exceeded the material yield strength prior to the separation.Excessive manipulation of the catheter is a possible contributing factor.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.Do not use if package is open or damaged.¿ 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.

• Brand Name: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORTATION; 14021 nw 60 avenue; miami lakes, fl 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, fl 33014
• Manufacturer Contact: karla castro ; 14021 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 17020636
• MDR Text Key: 316406637
• Report Number: 9616099-2023-06505
• Device Sequence Number: 1
• Product Code: DQO
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SRD5559
• Device Lot Number: 18153106
• 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: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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 Age: 68 YR
• Patient Sex: Male