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

Catalog Number	451543H0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, there was hair inside the package of the 5f small adult (c2) 100cm tempo diagnostic catheter.The procedure was completed by changing to another contrast catheter.There were no reports of patient injury.There were no damages found on the device packaging prior to opening.The sterile pouch was not received open or compromised.The condition was noted prior to using the device.It was stored in a cabinet in the lab.The actual product was not damaged.A sterile unit, "cath tempo 5f c2 100cm," was received for sealed in its original pouch with catalog number 451543h0 and lot number 18320197 seen on the labeling.Visual inspection revealed three kinked/bent sections on the catheter body at 28.0 cm, 56.0 cm, and 85.0 cm from the distal tip, which corresponds with folds on the pouch.Additionally, a hair was found inside the sealed pouch.No other damages or anomalies were observed on the returned device.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.During microscopic analysis, the hair found inside the sealed inner pouch was captured using the vision system.Additionally, kinked/ bent sections on the catheter body were observed.No other anomalies were noted during the microscopic examination.The fiber was extracted from the container for analysis by infrared spectroscopy to determine the composition of the contaminant and the results suggest the foreign material found inside the sealed pouch is a hair.The reported ¿packaging/pouch/box-foreign material in sterile package-movable particle¿ was confirmed.Infrared spectroscopy results indicated that the contaminant is consistent with the composition of hair, identified by the amide bands in the infrared spectrum.Additionally, kinked/bent sections were observed on the body of the unit, which aligned with folds in the pouch.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, ¿do not use if package is open or damaged.¿ a risk assessment has been opened to address events of packaging/pouch/box-foreign material in sterile package-movable particle has already been initiated.No further action will be taken at this time.
Event or Problem Description
As reported, there was hair inside the package of the 5f small adult (c2) 100cm tempo diagnostic catheter.The procedure was completed by changing to another contrast catheter.There were no reports of patient injury.There were no damages found on the device packaging prior to opening.The sterile pouch was not received open or compromised.The condition was noted prior to using the device.It was stored in a cabinet in the lab.The actual product was not damaged.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.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes
• 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: 21198251
• Report Number: 9616099-2025-00102
• Device Sequence Number: 20918137
• Product Code: DQO
• UDI-Device Identifier: 10705032008662
• UDI-Public: (01)10705032008662(17)270430(10)18320197
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Catalogue Number: 451543H0
• Device Lot Number: 18320197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2024
• 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: ANGIOGRAPHIC CATHETER, (B)(6), 2024.
• Patient Sex: Unknown