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

Model Number SRD5602

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  Injury  

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 Description

As reported, cardiologists reported 4 (four) different cases of aortic dissection 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 not available for evaluation.This case is related to (b)(4).

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: a4, b4, d4, g3, h1, h2, h3 and h6.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 intended procedure was a coronary angiogram; the right radial was accessed.There was a surgery performed after the dissection occurred.The coronary angiogram (cag) was okay, with clear coronaries.A judkins right was used to complete the procedure.The patient was transported umc amsterdam.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.

Event 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 intended procedure was a coronary angiogram; the right radial was accessed.There was a surgery performed after the dissection occurred.The coronary angiogram (cag) was okay, with clear coronaries.A judkins right was used to complete the procedure.The patient was transported umc amsterdam.The device is not available for evaluation.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.

• Brand Name: 5F TEMPO 0.038 100CM BL
• Type of Device: 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: 14831088
• MDR Text Key: 295057666
• Report Number: 9616099-2022-05758
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032048644
• UDI-Public: (01)10705032048644(17)240331(10)18018751
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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
• Device Operator: 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 09/08/2022
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 66 KG