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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 JUGULAR FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETR FILTER 55 JUGULAR FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220AJ
Device Problems Material Frayed (1262); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2018
Event Type  Malfunction  
Manufacturer Narrative

Facility name: (b)(6). 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. However, it will be submitted within 30 days upon receipt.

 
Event Description

During use, it was reported that an optease delivery sheath was used but it was confirmed that the distal end of the sheath was frayed. There was no patient injury. The device will be returned for analysis.

 
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Brand NameOPTEASE RETR FILTER 55 JUGULAR
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 00000
EI 00000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 00000
EI 00000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7946449
MDR Text Key123400303
Report Number9616099-2018-02436
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2019
Device MODEL Number466F220AJ
Device Catalogue Number466F220AJ
Device LOT Number17500964
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/26/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2016
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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