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

Catalog Number	451531H0
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
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.
Additional 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.
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; 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
• Report Number: 9616099-2023-06623
• Device Sequence Number: 7769180
• Product Code: DQO
• UDI-Device Identifier: 10705032008587
• UDI-Public: (01)10705032008587(17)250831(10)18147633
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 08/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 02/19/2024; 08/14/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 02/27/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Patient Sex: Unknown