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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has been received 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.
Event or Problem Description
As reported, a 5f 125cm tempo multipurpose small diagnostic catheter broke near the tip location during delivery to the target location.The device separated in two completely separate pieces.The operator immediately paused delivery of the catheter and took measures to remove the catheter and the broken segment.The separated piece was removed with an unknown guidewire and catheter.There was no reported patient injury.The procedure was a vertebral artery stenosis surgery.There was no abnormality of the catheter found before unpacking and before use.The catheter was delivered with an unknown guidewire.The device separated in the abdominal aorta, which had normal vessel characteristics, no calcification, no tortuosity, no stenosis, no acute angle, and no bifurcation.There was no resistance/friction noted between the catheter and guide prior to the separation.There was no excessive manipulation/torqueing of the catheter.The device will be returned for evaluation.
Additional Manufacturer Narrative
Section h6 impact/clinical codes corrected.
Additional Manufacturer Narrative
As reported, a 5f 125cm tempo multipurpose small diagnostic catheter broke near the tip while being delivered to the target location.The device separated in two pieces.The operator immediately paused delivery of the catheter and took measures to remove the catheter and the broken segment.The separated piece was removed with an unknown guidewire and catheter.There was no reported patient injury.The procedure was a vertebral artery stenosis surgery.There was no abnormality of the catheter found before unpacking and before use.The catheter was delivered with an unknown guidewire.The device separated in the abdominal aorta, which had normal vessel characteristics, no calcification, no tortuosity, no stenosis, no acute angle, and no bifurcation.There was no resistance/friction noted between the catheter and guide prior to the separation.There was no excessive manipulation/torquing of the catheter.One non-sterile cath tempo 5f mp a1 (i) 125cm unit was received for analysis.During visual inspection, it was noted that the brite tip/distal tip was not received for evaluation.As a result, a separation was noted approximately 120cm from the proximal end.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A high-magnification evaluation was conducted on the diagnostic catheter, and the separation identified during the visual analysis was confirmed.No other anomalies were detected during the high-magnification inspection.Sem analysis was performed on the separated section of the received catheter and the plastic material exhibited micro-elongations on both the internal (lumen) and external surfaces of the catheter.Additionally, material transfer was observed between what appears to be the plastic from the normal tip and the subsequent section of the tip.Micro-elongations and material transfer in plastic materials are commonly associated with localized tensile stress, deformation, and adhesion forces between previously bonded materials.Therefore, it is assumed that the catheter material was subjected to mechanical handling or tensile forces, contributing to the separation of the components.The presence of material transfer further supports the idea that both materials were originally bonded before the observed separation.The complaint reported by the customer as 'brite tip/distal tip - separated' was confirmed through product analysis and the findings suggest mechanical handling or tensile forces caused localized stress, leading to the separation.However, the exact source the excessive stress cannot be 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 product analysis and information available for review, there is no evidence that could be found to suggest the issue experienced is related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 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 ; 7863138372
• MDR Report Key: 20911679
• Report Number: 9616099-2024-00502
• Device Sequence Number: 7824262
• Product Code: DQO
• UDI-Device Identifier: 10705032008358
• UDI-Public: 10705032008358
• 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): 03/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 451506P0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 03/14/2025; 03/19/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/19/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 CATHETER; UNKNOWN GUIDEWIRES
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown