MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451514H0

Device Problem Partial Blockage (1065)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.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

During a diagnostic cerebral angiography, a thrombus developed as soon as the guidewire was withdrawn from the catheter and the patient had a stroke on the table.The catheter became clogged in a few seconds.The customer changed the catheter with a non cordis catheter and the procedure was finished with success and patient was not injured.Decision from physician to withdraw catheter from shelf having same lot number.

Manufacturer Narrative

Additional information was received that the patient did not have a stroke.Therefore, the event type was revised to a malfunction.During a diagnostic cerebral angiography, a thrombus developed as soon as the guidewire was withdrawn from the catheter.The catheter became clogged in a few seconds.The customer changed the catheter with a non cordis catheter and the procedure was finished with success and patient was not injured.The product was not returned for analysis.A product history record (phr) review of lot 17797905 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) obstructed - in-patient¿ and ¿thrombus in catheter¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural factors may have contributed to the reported event, as it is recommended that the patient should be considered for anticoagulation.According to the precautions in the safety information in the instructions for use ¿for all catheters: keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the phr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: CATH TEMPO 5F VER 135 DEGREE 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• MDR Report Key: 8579303
• MDR Text Key: 144012238
• Report Number: 9616099-2019-02895
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 451514H0
• Device Catalogue Number: 451514H0
• Device Lot Number: 17797905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NACL 09.% LIQUEFIED; NACL 09.% LIQUEFIED
• Patient Outcome(s): Life Threatening; Disability