TEMPO

Report

Report Number: 9616099-2025-01649
Event Type: Malfunction
Date Received: October 10, 2025
Date of Event: September 14, 2025
Report Date: December 5, 2025
Manufacturer: CORDIS US CORP.
Product Code: DQO
PMA / PMN Number: K973401
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AS REPORTED, THE OUTER LAYER OF SOME DISTAL CATHETER TIPS OF SIX 5F C2 100CM TEMPO DIAGNOSTIC CATHETERS WERE FOUND TO BE CRACKED, AND THE ACTUAL PRODUCT WAS FOUND TO BE DAMAGED, WITH THE OUTER LAYER OF THE CATHETER PEELING OFF. DEBRIS WAS ALSO FOUND INSIDE THE STERILE PACKAGING EVEN THOUGH THE ANGIOGRAPHIC CATHETER PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED UNDER NORMAL ROOM LIGHTING AND WAS HUNG IN A CABINET WITH TRANSPARENT DOORS IN THE OPERATING ROOM RATHER THAN KEPT IN THE WHITE OUTER BOX PRIOR TO USE. THE DEVICES WERE NOT EXPOSED TO A NON¿CLIMATE-CONTROLLED ENVIRONMENT BEFORE STORAGE IN THE LAB AND WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV LIGHTING OR OTHER STERILIZATION PROCESSES. THERE WAS NO DAMAGE NOTED ON THE PACKAGING PRIOR TO OPENING, AND THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE IN THE DESIGNATED HOSPITAL EQUIPMENT STORAGE ROOM. TWO IMAGES WERE PROVIDED, SHOWING THE PROXIMAL END OF A CATHETER INSIDE ITS POUCH WITH FRAGMENTS MISSING FROM THE STRAIN RELIEF AND BLUE POLYMER FLAKES INSIDE THE PACKAGING. ALL SIX DEVICES WERE RETURNED FOR EVALUATION AND WERE INVESTIGATED UNDER COMPLAINTS 2025-18226-1 THROUGH 2025-18226-6. 2025-18226-1 A STERILE UNIT OF ¿CATH TEMPO 5F C2 100CM¿ WAS RECEIVED IN THE ORIGINAL POUCH FOLDED INSIDE A PLASTIC BAG. THE UNIT WAS UNPACKED TO PERFORM THE VISUAL INSPECTION. THE POUCH SEALS ARE INTACT, AND THE STERILITY IS NOT COMPROMISED. THE CATHETER WAS INSPECTED FOCUSING ON THE STRAIN RELIEF OBSERVING A DEGRADATION CONDITION AND A YELLOWISH COLOR ON THE HUB. DEBRIS OF MATERIAL THAT DETACHED FROM THE STRAIN RELIEF CAN BE SEEN INSIDE THE PACKAGE. 2025-18226-2 A STERILE UNIT OF ¿CATH TEMPO 5F C2 100CM¿ WAS RECEIVED IN THE ORIGINAL POUCH FOLDED INSIDE A PLASTIC BAG. THE UNIT WAS UNPACKED TO PERFORM THE VISUAL INSPECTION. THE POUCH SEALS ARE INTACT, AND THE STERILITY IS NOT COMPROMISED. THE CATHETER WAS INSPECTED FOCUSING ON THE STRAIN RELIEF OBSERVING A DEGRADATION CONDITION AND A YELLOWISH COLOR ON THE HUB. DEBRIS OF MATERIAL THAT DETACHED FROM THE STRAIN RELIEF CAN BE SEEN INSIDE THE PACKAGE. 2025-18226-3 A STERILE UNIT OF ¿CATH TEMPO 5F C2 100CM¿ WAS RECEIVED IN THE ORIGINAL POUCH FOLDED INSIDE A PLASTIC BAG. THE UNIT WAS UNPACKED TO PERFORM THE VISUAL INSPECTION. THE POUCH SEALS ARE INTACT, AND THE STERILITY IS NOT COMPROMISED. THE CATHETER WAS INSPECTED FOCUSING ON THE STRAIN RELIEF OBSERVING A DEGRADATION CONDITION AND A YELLOWISH COLOR ON THE HUB. DEBRIS OF MATERIAL THAT DETACHED FROM THE STRAIN RELIEF CAN BE SEEN INSIDE THE PACKAGE. 2025-18226-4 A STERILE UNIT OF ¿CATH TEMPO 5F C2 100CM¿ WAS RECEIVED IN THE ORIGINAL POUCH FOLDED INSIDE A PLASTIC BAG. THE UNIT WAS UNPACKED TO PERFORM THE VISUAL INSPECTION. THE POUCH SEALS ARE INTACT, AND THE STERILITY IS NOT COMPROMISED. THE CATHETER WAS INSPECTED FOCUSING ON THE STRAIN RELIEF OBSERVING A DEGRADATION CONDITION AND A YELLOWISH COLOR ON THE HUB. DEBRIS OF MATERIAL THAT DETACHED FROM THE STRAIN RELIEF CAN BE SEEN INSIDE THE PACKAGE. 2025-18226-5 A STERILE UNIT OF ¿CATH TEMPO 5F C2 100CM¿ WAS RECEIVED IN THE ORIGINAL POUCH FOLDED INSIDE A PLASTIC BAG. THE UNIT WAS UNPACKED TO PERFORM THE VISUAL INSPECTION. THE POUCH SEALS ARE INTACT, AND THE STERILITY IS NOT COMPROMISED. THE CATHETER WAS INSPECTED FOCUSING ON THE STRAIN RELIEF OBSERVING A DEGRADATION CONDITION AND A YELLOWISH COLOR ON THE HUB. DEBRIS OF MATERIAL THAT DETACHED FROM THE STRAIN RELIEF CAN BE SEEN INSIDE THE PACKAGE. 2025-18226-6 A STERILE UNIT OF ¿CATH TEMPO 5F C2 100CM¿ WAS RECEIVED IN THE ORIGINAL POUCH FOLDED INSIDE A PLASTIC BAG. THE UNIT WAS UNPACKED TO PERFORM THE VISUAL INSPECTION. THE POUCH SEALS ARE INTACT, AND THE STERILITY IS NOT COMPROMISED. THE CATHETER WAS INSPECTED FOCUSING ON THE STRAIN RELIEF OBSERVING A DEGRADATION CONDITION AND A YELLOWISH COLOR ON THE HUB. DEBRIS OF MATERIAL THAT DETACHED FROM THE STRAIN RELIEF CAN BE SEEN INSIDE THE PACKAGE. THE REPORTED ¿STRAIN RELIEF¿DEGRADATION¿ WAS OBSERVED ON ALL SIX RETURNED DEVICES. BASED ON THE AVAILABLE INFORMATION, THE SPECIFIC CAUSE OF THE DEGRADATION COULD NOT BE DETERMINED. POTENTIAL CONTRIBUTING FACTORS INCLUDE STORAGE OR HANDLING CONDITIONS WITHIN THE REPORTING FACILITY OR FACTORS ASSOCIATED WITH THE MANUFACTURING PROCESS OF THE UNIT. USERS ARE TRAINED TO INSPECT PRODUCTS FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE, AND ANY PRODUCT SHOWING DAMAGE IS NOT TO BE USED. THE PRODUCT LABELING INCLUDES INFORMATION FOR SAFETY INTENDED TO MAKE USERS AWARE OF SUCH RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. DO NOT EXPOSE TO ORGANIC SOLVENTS.¿ BECAUSE A POTENTIAL LINK TO THE MANUFACTURING PROCESS COULD NOT BE EXCLUDED, AN INVESTIGATION HAS BEEN INITIATED TO FURTHER EVALUATE POTENTIAL CONTRIBUTING FACTORS AND IMPLEMENT FURTHER ACTIONS AS APPROPRIATE. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

AS REPORTED, THE OUTER LAYER OF SOME DISTAL CATHETER TIPS OF SIX 5F C2 100CM TEMPO DIAGNOSTIC CATHETERS WAS FOUND TO BE CRACKED, AND THE ACTUAL PRODUCT WAS FOUND TO BE DAMAGED, WITH THE OUTER LAYER OF THE CATHETER PEELING OFF. DEBRIS WAS ALSO FOUND INSIDE THE STERILE PACKAGING EVEN THOUGH THE ANGIOGRAPHIC CATHETER PACKAGES HAD NOT BEEN OPENED. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES NOTED ON THE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE AND WAS KEPT IN THE DESIGNATED HOSPITAL EQUIPMENT STORAGE ROOM. THE SIX DEVICES WILL BE RETURNED FOR EVALUATION. TWO IMAGES WERE PROVIDED, AND THEY SHOW THE PROXIMAL END OF A CATHETER INSIDE ITS POUCH. FRAGMENTS ARE MISSING FROM THE STRAIN RELIEF WITH THE BLUE POLYMER FLAKES SEEN INSIDE THE PACKAGING. THE SIX DEVICES WILL BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2112456	TEMPO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	CORDIS US CORP.	NA	18253811

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown