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

Catalog Number	SRD5559
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: 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 ; 7863138372
• MDR Report Key: 18529191
• Report Number: 9616099-2024-00019
• Device Sequence Number: 6402306
• Product Code: DQO
• UDI-Device Identifier: 10705032048545
• UDI-Public: (01)10705032048545(17)250331(10)18101025
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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
• Patient Sex: Unknown