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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3 100CM CATHETER, PERCUTANEOUS

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CORDIS CORPORATION 6F .070 XB 3 100CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17967466 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, there was a reddish clot like substance in the lumen of a 6f. 070 100cm vista brite tip extra back-up (xb) guiding catheter. The procedure was completed using another unknown guide catheter. There was no reported patient injury. The device was opened in sterile field. The procedure was a percutaneous transluminal coronary angioplasty (ptca) with stent placement of the proximal circumflex (lcx) and mid left anterior descending artery (lad) using a right femoral approach. The lcx had 90% stenosis and the lad had 90% stenosis. Other procedural details were requested but are unknown, unavailable, or not applicable. The device will be returned for evaluation. Photographs were provided and available for review.

 
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Brand Name6F .070 XB 3 100CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key11617948
MDR Text Key243931872
Report Number9616099-2021-04388
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK021593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number67005200
Device LOT Number17967466
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/16/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/25/2020
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: 04/06/2021 Patient Sequence Number: 1
Treatment
BMW GUIDEWIRE; UNKNOWN GUIDE CATHETER; YUKON CHOICE 2.75X12MM PC ELITE DES STENT; YUKON CHOICE 3.0X18MM PC ELITE DES STENT
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