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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION CATH TEMPO 4F C2 65CM 2SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
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.
 
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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 Key7438006
MDR Text Key105725985
Report Number9616099-2018-02057
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K973401
Number of Events Reported1
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 Date03/31/2019
Device Catalogue Number451443V2
Device Lot Number17470606
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/19/2018
Initial Date FDA Received04/17/2018
Supplement Dates Manufacturer Received05/07/2018
Supplement Dates FDA Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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