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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 45CM STR INTRODUCER, CATHETER

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CORDIS CORPORATION SI BRITE TIP 7F 45CM STR INTRODUCER, CATHETER Back to Search Results
Model Number 401745M
Device Problems Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18072094 presented no issues during the manufacturing process that can be related to the reported event. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 7f str brite tip catheter sheath introducer (csi) kinked in "the bifurcation massively". It was "heavy" to pull the devices out, with the handling the brite tip csi expanded near the kink. The material "got less" (color got more transparent) and became softer. The physician was afraid, that the sheath could tear off. He needed a lot of "material" to pull the sheath out. The way for this success was, to inflate a. 018 saber balloon catheter in the near of the tip of the sheath and pull the balloon and the sheath together out of the patient. The patient was not harmed. There was no reported patient injury. The device was stored and prepped according to the instructions for use. The sheath was in place for 15 minutes. The sheath was not used for any infusions other than contrast media. The procedure was an endovascular treatment of stenosis of the left leg. The procedure used a crossover from the common femoral artery into the right external and common iliac artery, ending in the left common iliac artery ( which was covered with an old nitinol stent). The vessel was severely calcified, mildly tortuous, with mild stenosis and moderate bifurcation. The first treatment with standard material was not successful, therefore the physician decided to exchange for a poenix arteriotomy device. The device will be returned for evaluation.
 
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Brand NameSI BRITE TIP 7F 45CM STR
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key14959637
MDR Text Key295526534
Report Number9616099-2022-05791
Device Sequence Number1
Product Code DYB
UDI-Device Identifier20705032000335
UDI-Public(01)20705032000335(17)241130(10)18072094
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K984500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number401745M
Device Catalogue Number401745M
Device Lot Number18072094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/08/2022 Patient Sequence Number: 1
Treatment
POENIX ARTERIOTOMY DEVICE; SABER .018 BALLOON
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