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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM CATHETER, PERCUTANEOUS

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CORDIS CORPORATION 6F .070 XB 3.5 100CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 67005400
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2021
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18000514 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, the head-end of 6f. 070 3. 5 100cm vista brite tip extra back-up (xb) guiding catheter was frayed/split/torn. Therefore, the device was replaced with another vista brite tip catheter to complete the operation. This event had no effect on the patient and there was no reported patient injury. The patient had more than 80% stenosis of right coronary artery and percutaneous coronary intervention (pci) was needed. The device was stored in the lab according to the ifu for 15 days. The device was stored and handled per the ifu. The device will be returned for evaluation.

 
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Brand Name6F .070 XB 3.5 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 Key12136397
MDR Text Key260515341
Report Number9616099-2021-04692
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number67005400
Device Catalogue Number67005400
Device LOT Number18000514
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2021
Is The Reporter A Health Professional? Yes
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 Manufactured02/02/2021
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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