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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL
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COOK INC CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL Back to Search Results
Catalog Number VRS-6.0-90
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 10/30/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that during preparation the clover snare retriever snapped off prior to contact with the patient.Another device was used to complete the procedure successfully.
 
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Brand Name
CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER
Type of Device
MMX DEVICE, PERCUTANEOUS RETRIEVAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7480412
MDR Text Key107504007
Report Number1820334-2018-01350
Device Sequence Number1
Product Code MMX
UDI-Device Identifier10827002530086
UDI-Public(01)10827002530086(17)160301(10)3583504
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVRS-6.0-90
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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