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

Catalog Number 451443V0

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the customer reported finding 4f tempo 65 cm angiographic catheters still in sterile package: however, damaged, and unusable.They claim to have received the product in this fashion.A picture showing three (3) sterile tempo catheters was provided for review and pieces of the coating on the catheters appear to be flaking off the devices.The products were never opened or used in the patient.There was no reported patient injury.The exact event date is unknown.This complaint involves two (2) tempo catheters of lot number 18168805.The condition was noticed prior to use.There was no damage to the shipping box, no damage to the outer product box or the inner product pouch.The sterile pouch was not received open/compromised.The products are stored in the lab hanging in racks.The devices are expected to be returned for evaluation.

• Brand Name: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 19111631
• MDR Text Key: 340832565
• Report Number: 9616099-2024-00113
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008051
• UDI-Public: 10705032008051
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

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: 451443V0
• Device Lot Number: 18168805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Date Device Manufactured: 12/03/2022
• 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