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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JL3.5 100CM CATHETER, PERCUTANEOUS

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CORDIS CORPORATION 6F .070 JL3.5 100CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 67000200
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  Malfunction  
Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device was received for analysis, but the engineering report is not yet available. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During prep, when a 6f. 070 jl3. 5 100cm vista brite tip guiding catheter was used and it was found that the head end was damaged (frayed/split). It was then replaced with another guide catheter (unknown) to complete the operation. There was no reported patient injury. The patient had a history of coronary heart disease and pericardial pain and was admitted to the hospital. Angiographic examination showed that more than eighty percent (80%) of the left anterior descending coronary artery was stenosis, along with seventy percent (70%) calcification and needed percutaneous coronary intervention (pci) treatment. There were no damages noted to the device packaging. There were no difficulties removing the product from the packaging. The brite tip was prepped in accordance with the instruction for use (ifu). There were no excessive force used anytime during the procedure. The device will be returned for evaluation. No other information was provided.

 
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Brand Name6F .070 JL3.5 100CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th avenue
miami lakes, FL 33014
7863138372
MDR Report Key11995714
MDR Text Key256751208
Report Number9616099-2021-04638
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK021593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number67000200
Device Catalogue Number67000200
Device LOT Number17971483
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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