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

Catalog Number	451530H0
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the packaging for a 5f100cm sidewinder simmons 1 (sim1) tempo diagnostic catheter was found damaged upon opening.An image was provided which displays a torn inner package.Another 5f100cm sim1 tempo diagnostic catheter was used as a replacement.There were no reported injuries to the patient.The device was stored and opened according to the instructions for use (ifu).No damage was found on the device itself.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 information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the packaging for a 5f100cm sidewinder simmons 1 (sim1) tempo diagnostic catheter was found damaged upon opening.An image was provided which displays a torn inner package.Another 5f100cm sim1 tempo diagnostic catheter was used as a replacement.There were no reported injuries to the patient.The device was stored and opened according to the instructions for use (ifu).No damage was found to the device itself.One image was sent for review, and it shows the catheter mounted on cardboard inside the pouch, with the pouch showing a torn condition.No other details were observable in the image provided.Based on the available photograph, there is insufficient information to determine whether a manufacturing-related issue is present.The cath tempo 5f sim 1 100cm device involved in the reported complaint was subsequently returned for investigation.Visual inspection identified that the pouch bag in which the unit was received exhibited a tear rupture.The received unit was contained within this torn pouch at the time of evaluation.The product analysis did not find evidence to suggest that the observed condition was related to the manufacturing or design process.The reported ¿packaging/pouch/box ¿ frayed/split/torn ¿ inner package¿ was found during the product evaluation.The exact cause of the reported event cannot be found, and handling factors cannot be excluded as a potential 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 of making the user aware of the risks.According to the instructions for use (ifu), ¿do not use if package is open or damaged.¿ 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 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: 24164346
• Report Number: 9616099-2026-00140
• Device Sequence Number: 15770204
• Product Code: DQO
• UDI-Device Identifier: 10705032008563
• UDI-Public: (01)10705032008563(17)260731(10)18233890
• 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): 02/12/2026

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: 07/31/2026
• Device Catalogue Number: 451530H0
• Device Lot Number: 18233890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2023
• 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: 5F100CM SIM1 TEMPO DIAGNOSTIC CATHETER.
• Patient Sex: Unknown