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

Catalog Number SRD5559

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/03/2023

Event Type  malfunction  

Event Description

As reported, when opening four (4) 5f tempo 0.038 125cm guiding catheters were found broken distally (curvature) and proximally.The devices could not be used.There was no reported patient injury.The damage was noticed during the procedure.The shape of the body/shaft was described as "like turtle or fish scales at the shape"(tiny pieces cracked but still attached to one point on the catheter).The braided core wire was not exposed and it is unknown if the catheters were delaminated or compressed crushed as it was further clarified.The products were stored, handled, and prepped according to the instructions for use (ifu) and there was no device damage noticed prior to opening the packages or difficulty removing the devices from the sterile packaging.There was no difficulty experienced in prepping the devices.The procedure was completed using an unknown cordis device with a different shape.All 4 devices were discarded at site after the procedure and will not be returned for evaluation.Pictures are not available.

Manufacturer Narrative

As reported, four (4) 5f tempo 0.038 125cm guiding catheters were found broken distally (curvature) and proximally after opening.The devices could not be used.There was no reported patient injury.The damage was noticed during the procedure.The shape of the body/shaft was described as "like turtle or fish scales at the shape"(tiny pieces cracked but still attached to one point on the catheter).The braided core wire was not exposed and it is unknown if the catheters were delaminated or compressed crushed as it was further clarified.The products were stored, handled, and prepped according to the instructions for use (ifu) and there was no device damage noticed prior to opening the packages or difficulty removing the devices from the sterile packaging.There was no difficulty experienced in prepping the devices.The procedure was completed using an unknown cordis device with a different shape.All 4 devices were discarded at site after the procedure and will not be returned for evaluation.Without the return of the devices or images for analysis, the reported customer event ¿coating-delaminated¿ could not be confirmed for any of the affected devices.Shipping, storage, or handling factors may have contributed to the reported event.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 open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ based on the information available and the phr review, 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.; 14201 nw 60th avenue; miami lakes, florida 33014
• 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: 18529191
• MDR Text Key: 333381403
• Report Number: 9616099-2024-00019
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032048545
• UDI-Public: 10705032048545
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SRD5559
• Device Lot Number: 18101025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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