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

Catalog Number	451531H0
Medical Device Problem Codes	Crack (1135); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the four 5f tempo sim2 contrast catheters had cracks.The cracks were located on the body of the catheter, which were noticed during preparation.The issue was discovered when opening the packaging.The procedure was completed by changing to another tempo device.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored hanging in the disposable's cabinet.The device was prepped per the ifu, but it was not used.The access site was femoral, and the intended procedure targeted carotid artery stenosis.The lesion was little calcified, with no vessel tortuosity noted.The device will be returned for evaluation.
Additional 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 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.
Event or Problem Description
As reported, the four 5f tempo sim2 contrast catheters had cracks.The cracks were located on the body of the catheter, which were noticed during preparation.The issue was discovered when opening the packaging.The catheters were found to have degradation.The procedure was completed by changing to another tempo device.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored hanging in the disposable's cabinet.The device was prepped per the ifu, but it was not used.The access site was femoral, and the intended procedure targeted carotid artery stenosis.The lesion was little calcified, with no vessel tortuosity noted.These devices were no exposed to any uv light during the procedure.These devices were no exposed to high temperatures.It is unknown if the devices came from the same box.The device will be returned for evaluation.
Event or Problem Description
As reported, the four 5f tempo sim2 contrast catheters had cracks.The cracks were located on the body of the catheter, which were noticed during preparation.The issue was discovered when opening the packaging.The catheters were found to have degradation.The procedure was completed by changing to another tempo device.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored hanging in the disposable's cabinet.The device was prepped per the ifu, but it was not used.The access site was femoral, and the intended procedure targeted carotid artery stenosis.The lesion was little calcified, with no vessel tortuosity noted.These devices were no exposed to any uv light during the procedure.These devices were no exposed to high temperatures.It is unknown if the devices came from the same box.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the four 5f tempo sim2 contrast catheters had cracks.The cracks were located on the body of the catheter, which were noticed during preparation.The issue was discovered when opening the packaging.The catheters were found to have degradation.The procedure was completed by changing to another tempo device.There was no reported injury to the patient.There was no damage to the packaging of the device.The product was stored hanging in the disposable's cabinet.The device was prepped per the ifu, but it was not used.The access site was femoral, and the intended procedure targeted carotid artery stenosis.The lesion was little calcified, with no vessel tortuosity noted.These devices were not exposed to any uv light during the procedure.These devices were not exposed to high temperatures.It is unknown if the devices came from the same box.One non-sterile ¿cath tempo 5f sim 2 100cm¿ unit was received for analysis.During the visual inspection, severe cracks and an irregular texture were noted along the catheter body, and a different coloration of the catheter hub was seen.No other anomalies were found during the visual analysis.Dimensional analysis could not be performed on the returned device due to the severely cracked condition and irregular texture cracks seen in the catheter body.The microscopic examination involved capturing amplified images of the catheter and presented evidence of a severely cracked condition, micro-elongations, micro fissures, and an irregular texture on the plastic of the catheter body.Additionally, the returned device was compared to a lab sample diagnostic catheter and a yellowish color was seen on the hub of the returned device.It should also be noted that no signs of mechanical stress such as damage to the braid wire were seen during the analysis.No other anomalies were found during the microscopic analysis.The complaint reported by the customer as catheter (body/shaft)-cracked and catheter (body/shaft)-degradation were confirmed.Visual and microscopic inspection revealed a severely cracked condition, micro elongations, micro fissures, and irregular texture.Additionally, a yellowish discoloration was seen on the hub of the returned device in comparison to a lab sample catheter.These findings along with the absence of mechanical stress suggest the malfunctions may be secondary to environmental exposure such as uv radiation, thermal stress, or chemical agents however, the root cause has not been conclusively determined.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 available information and product analysis, the cause of the degradation could not be determined; however, it is potentially related to the manufacturing process of the unit.Therefore, an investigation has been initiated to further review the potential causes.No further action will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 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 ; 7863138372
• MDR Report Key: 20704309
• Report Number: 9616099-2024-00407
• Device Sequence Number: 13164416
• Product Code: DQO
• UDI-Device Identifier: 10705032008587
• UDI-Public: (01)10705032008587(17)250630(10)18131631
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 451531H0
• Device Lot Number: 18131631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/14/2025; 02/12/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/07/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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
• Patient Sex: Unknown