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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CARDINAL HEALTH MEXICO OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2020
Event Type  Malfunction  
Manufacturer Narrative

Telephone number is (b)(6). The device was returned but the engineering report is pending. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

There was difficulty when advancing the filter and it punctured the sheath during delivery of the filter through the sheath. The filter was withdrawn and replaced with another one to complete the procedure. The patient was not morbidly obese, and the approach was not tortuous. The product was stored and handled per ifu. There was no difficulty prepping the devices. The sheath was flushed prior to insertion into the patient and there was no difficulty inserting the filter into the sheath. There was no excessive force used. The filter was no longer within the storage tube when it punctured the delivery sheath. The device was returned for analysis. Patient information was requested but was not available.

 
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Brand NameOPTEASE RETR FILTER 55
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer (Section G)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX 11000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key11088070
MDR Text Key224521402
Report Number9616099-2020-04156
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK034050
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,Followup
Report Date 01/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number466F210A
Device LOT Number17881976
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/30/2019
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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