MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F C2 65CM 2SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451443V2

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

A product history record (phr) review of lot 17470606 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be submitted within 30 days upon receipt.(b)(4).

Event Description

As reported, the yellow marker at the tip of catheter came off and embolised, lodging in cauda right atrium.A decision was made not to attempt retrieval as small and likely not to cause a problem.Later, there was some difficulty passing catheter through interstices of stent immediately prior to event; however, no significant force required to pass it and eventually went through easily with some torquing of catheter.There was no reported patient injury.The device will not be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.During an unknown procedure, the yellow marker at the tip of a 4 french tempo catheter came off and embolized, lodging in the ¿cauda right atrium.¿ there was no reported patient injury.A decision was made not to attempt retrieval as its small size would likely not cause a problem.There was some difficulty passing the catheter through the interstices of stents immediately prior to event; however, no significant force was required to pass it and eventually it went through easily with some torqueing of the catheter.The device was not returned for analysis.A review of the manufacturing documentation associated with lot 17470606 was performed and no issues were noted that were related to the reported complaint.The reported ¿brite tip/distal tip-catheters separated - in-patient¿ and ¿catheter (body/shaft) tracking difficulty - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, while unknown, may have contributed to the reported event as high degrees of tortuosity and stenosis are known to cause damage to catheters.Handling factors may have also contributed to the event as catheters are delicate devices.According to the instructions for use, which is not intended as a mitigation ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi).Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the phr (product history report) review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH TEMPO 4F C2 65CM 2SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7438006
• MDR Text Key: 105725985
• Report Number: 9616099-2018-02057
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 451443V2
• Device Lot Number: 17470606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention