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

Catalog Number	451531H0
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, cracks were noted on the 5f 100 cm sidewinder ii (sim 2) tempo contrast catheter.The procedure was completed using another tempo catheter.There was no reported patient injury.The intended procedure was for carotid artery stenosis.The term ¿cracked¿ refers to the polymer material of the device breaking but not into two or more pieces.The damage, which included many cracks on the surface of the angiographic tube, was noticed when the package was opened, specifically on the body shaft.A picture of the damaged device was provided.The issue was noticed during preparation.The target lesion was carotid artery stenosis with seventy percent (70%) stenosis, no calcification, and no tortuosity.Anomalies were noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device was not used, so no difficulties, resistance, or unusual force were experienced during the procedure.The tip was not visible on fluoroscopy as the device was not used.The device was returned for evaluation.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18110255 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, cracks were noted on the 5f 100 cm sidewinder ii (sim 2) tempo contrast catheter.The procedure was completed using another tempo catheter.There was no reported patient injury.The intended procedure was for carotid artery stenosis.The term ¿cracked¿ refers to the polymer material of the device breaking but not into two or more pieces.The damage, which included many cracks on the surface of the angiographic tube, was noticed when the package was opened, specifically on the body shaft.A picture of the damaged device was provided.The issue was noticed during preparation.The target lesion was carotid artery stenosis with seventy percent (70%) stenosis, no calcification, and no tortuosity.Anomalies were noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).The device was not used, so no difficulties, resistance, or unusual force were experienced during the procedure.The tip was not visible on fluoroscopy as the device was not used.The device was returned for evaluation.A unit of catheter cath tempo 5f sim 2 100cm was received coiled inside of a clear plastic bag and unpacked for evaluation.Inspection showed that the body/shaft was separated 90 cm from the proximal end, with the separated 10 cm distal part returned for analysis.The fusion line was visible on the distal part, indicating the separation was not related to a fusion process issue.Outer and inner diameter measurements were taken near the separation and found within specification.High magnification evaluation revealed evidence of material elongation patterns at the separation borders, consistent with exposure to excessive tensile force, as well as cracks in the region.To assess potential material defects or degradation, ftir analysis was conducted and compared to a cordis-manufactured sample.The spectral comparison showed no significant differences in chemical composition in either the hub or the cracked areas analyzed.A product history record (phr) review of lot 18110255 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported catheter (body/shaft)-cracked was seen during the product evaluation and the malfunction catheter (body/shaft)-separated was also observed.The exact cause of these damages is unknown; however, they may be related to handling factors.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 of making 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 evidence to suggest 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
• Common Device Name: 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: 20608854
• Report Number: 9616099-2024-00359
• Device Sequence Number: 7909882
• Product Code: DQO
• UDI-Device Identifier: 10705032008587
• UDI-Public: (01)10705032008587(17)250430(10)18110255
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 451531H0
• Device Lot Number: 18110255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 03/18/2025; 08/15/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/18/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• 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