MAUDE Adverse Event Report: CORDIS CORPORATION 5F TEMPO 0.038 100CM BL; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	SRD5602
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, cardiologists reported 4 (four) different cases of aortic dissections while using the 5f tempo (5f tempo 0.038 100c bl) brachial left catheter.Three (3) different cardiologists from the same hospital recently reported the same kind of complication all with product code srd5602.They have been using this product for years.The incident was reported at the dutch health care inspectorate and cardiologists are calling other doctors to see if they have experienced the same kind of complication with this catheter.The device is expected to be return for evaluation.
Event or Problem Description
As reported, a cardiologist reported a case of aortic dissection while using the 5f tempo (5f tempo 0.038 100c bl) brachial left catheter.The device is not available for evaluation.The intended procedure was a coronary angiogram; the right radial was accessed.After contrast injection, contrast was noted to be in the aortic wall at the level of right coronary.The procedure was stopped, and patient was transported to another facility.Patient experienced pain in the chest.The facility decided not to treat; therefore, no stent was placed.The intended procedure was completed at the facility, and the coronaries were clean.Afterwards patient came back, and no complaints were reported afterwards.There was no vessel calcification, tortuosity or stenosis.The device was not used for a chronic total occlusion.The device was stored, handled, and prepped per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package, and no anomalies noted during or after the device was prepped.Unusual force was not used at any time during the procedure; neither resistance met while advancing the device nor torquing required.Another device was used to complete the procedure.The event did not cause a clinically relevant increase in the duration of the procedure.The event caused a condition that required hospitalization or significant prolongation of existing hospitalization.A procedural cd is not available for review.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6.As reported, a cardiologist reported an aortic dissection while using a 5f tempo (5f tempo 0.038 100c bl) brachial left catheter.The device is not available for evaluation.The intended procedure was a coronary angiogram; the right radial artery was accessed.After contrast injection, contrast was noted to be in the aortic wall at the level of right coronary.The procedure was stopped, and the patient was transported to another facility.Patient experienced chest pain.The facility decided not to treat; therefore, no stent was placed.The intended procedure was completed at the facility, and the coronaries were clean.Afterwards patient came back, and no complaints were reported.There was no vessel calcification, tortuosity, or stenosis.The device was not used for a chronic total occlusion.The device was stored, handled, and prepped per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no anomalies noted when the device was taken out of the package, and no anomalies noted during or after the device was prepped.Unusual force was not used at any time during the procedure; neither resistance met while advancing the device nor torquing required.Another device was used to complete the procedure.The event did not cause a clinically relevant increase in the duration of the procedure.The event caused a condition that required hospitalization or significant prolongation of existing hospitalization.The product was not returned for analysis.A product history record (phr) review of lot 18018751 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 or images for analysis, the reported customer event ¿aortic dissection¿ could not be confirmed.Patient specific vessel characteristics and/or damaging the catheter tip during removal from the package 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, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Possible complications include but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of the vessel wall¿ 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: 5F TEMPO 0.038 100CM BL
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14832164
• Report Number: 9616099-2022-05759
• Device Sequence Number: 2367813
• Product Code: DQO
• UDI-Device Identifier: 10705032048644
• UDI-Public: (01)10705032048644(17)240331(10)18018751
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SRD5602
• Device Catalogue Number: SRD5602
• Device Lot Number: 18018751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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