MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F PIG 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451403V5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18101155 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the upper part of 4f pigtail 5 side holes (sh) tempo catheter was observed to be fracture and does not allow the proper use of this "input".There was no reported patient injury.The procedure was a diagnostic test.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: a2, a3, a4, b5, b7, d10, g3, g6, h1, h2, and h10.
Event or Problem Description
As reported, the upper part of 4f pigtail 5 side holes (sh) tempo catheter was observed to be fracture and does not allow the proper use of this "input".The damage was noted inside the patient.The procedure was completed with another pig tail catheter.There was no reported patient injury.The product was handled with the proper institutional instructions.The intended procedure was a thoracic aortogram.The vessel had no aorta tortuosity.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the upper part of 4f pigtail 5 side holes (sh) tempo catheter was observed to be fracture and does not allow the proper use of this "input".The damage was noted inside the patient.The procedure was completed with another pig tail catheter.There was no reported patient injury.The product was handled with the proper institutional instructions.The intended procedure was a thoracic aortogram.The vessel had no aorta tortuosity.The product was not returned for analysis.A product history record (phr) review of lot 18101155 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device the reported ¿catheter-cracked¿ could not be confirmed or further clarified.Procedural handling factors such as device damage upon removal from the packaging or while attempting to connect to another device can contribute 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, ¿to prevent damage to the catheter during removal from the package, grasp the hub and withdraw the catheter.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: CATH TEMPO 4F PIG 65CM 5SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15653636
• Report Number: 9616099-2022-06064
• Device Sequence Number: 11361270
• Product Code: DQO
• UDI-Device Identifier: 10705032007719
• UDI-Public: (01)10705032007719(17)250331(10)18101155
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 12/09/2022

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 Model Number: 451403V5
• Device Catalogue Number: 451403V5
• Device Lot Number: 18101155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 12/07/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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: ANOTHER PIG TAIL CATHETER
• Patient Age: 5 MO
• Patient Sex: Female
• Patient Weight: 4 KG