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

Catalog Number	451457V0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a 4f 65cm rim tempo diagnostic catheter tore when withdrawn over the bifurcation and had to be retrieved with a snare.There was no reported patient injury.During use, the device cracked ; there was no device separation, and the catheter did not become entrapped.Snare retrieval was identified as the anticipated method; however, no separation occurred.The product was stored/handled and prepped per the ifu, with no damage noted prior to opening and no difficulty removing from packaging or during preparation.The device was removed from sterile packaging by the hub and was not torqued/steered by the hub.Target vessel characteristics included mild calcification.The access site vessel characteristics were not reported.Procedural imaging (cd) is not available.The device was returned for evaluation.
Additional Manufacturer Narrative
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As reported, a 4f 65cm rim tempo diagnostic catheter tore when withdrawn over the bifurcation and had to be retrieved with a snare.There was no reported patient injury.During use, the device cracked and the catheter did not become entrapped.Snare retrieval was identified as the anticipated method.The distal tip was the part which was snared.It was separated so they had e to snare the distal part.The product was stored/handled and prepped per the ifu, with no damage noted prior to opening and no difficulty removing from packaging or during preparation.The device was removed from sterile packaging by the hub and was not torqued/steered by the hub.Target vessel characteristics included mild calcification.The access site vessel characteristics were not reported.Procedural imaging (cd) is not available.A non-sterile cath tempo 4f rim 65cm catheter was received coiled inside a clear plastic bag.Visual inspection confirmed the distal tip was separated approximately 65 cm from the hub, with no other visible damage noted.Dimensional analysis verified that the inner and outer diameters were within specification.Amplified imaging of the separated distal tip showed elongation of the plastic material consistent with tensile stress beyond the elastic limit, suggesting that the distal end was subjected to excessive tensile load prior to separation.No evidence of manufacturing or assembly deficiencies was identified during the evaluation.The reported malfunction ¿brite tip/distal tip ¿ separated¿ was observed during the evaluation.The exact cause of the reported event cannot be determined through this investigation; however, procedure-related factors based on the signs of excessive tensile stress may be a contributing factor.Information for safety is provided in the product¿s 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, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ and ¿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 available information and product analysis, 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 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23051580
• Report Number: 9616099-2025-01463
• Device Sequence Number: 9824904
• Product Code: DQO
• UDI-Device Identifier: 10705032008174
• UDI-Public: (01)10705032008174(17)280531(10)18459149
• 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
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 451457V0
• Device Lot Number: 18459149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White