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

Catalog Number 451531H0

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2023

Event Type  malfunction  

Event Description

As reported, a hole was found in the outer packaging of a 100cm tempo sidewinder ii (sid) angiographic catheter, which disrupted the sterile condition and prevented the use of the catheter.A new angiography catheter of the same size was used to complete the procedure.There were no reports of patient injury.The condition of the original package was noted during prep, when unpacking the product.The whole box was kept in the ¿consumable¿ cabinet in the operating room.The product was not damaged, but the sterile environment was broken.The device will be returned for evaluation.

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.

Manufacturer Narrative

Complaint conclusion: as reported, a hole was found in the outer packaging of a 100cm tempo sidewinder ii (sid) angiographic catheter, which disrupted the sterile condition and prevented the use of the catheter.A new angiography catheter of the same size was used to complete the procedure.There were no reports of patient injury.The condition of the original package was noted during prep, when unpacking the product.The whole box was kept in the ¿consumable¿ cabinet in the operating room.The product was not damaged, but the sterile environment was broken.A non-sterile unit of ¿cath tempo 5f sim 2 100cm¿ was received for analysis.The original packaging/pouch was not included in the returned shipment.The unit presented with several kinks located approximately 42, 73 and 84 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The reported ¿packaging/pouch/box-compromised sterility¿ could not be confirmed because the original packaging was not returned for analysis.However, several kinks were noted on the body/shaft.Shipping/handling factors may be the cause of the observed damages.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 available information, there is no indication that 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14021 nw 60 avenue; miami lakes, florida 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: 18066357
• MDR Text Key: 327297737
• Report Number: 9616099-2023-06623
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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 Operator: Health Professional
• Device Catalogue Number: 451531H0
• Device Lot Number: 18147633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.