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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FILMECC CO., LTD. VASSALLO GT; GUIDE WIRE
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FILMECC CO., LTD. VASSALLO GT; GUIDE WIRE Back to Search Results
Catalog Number VGT14300XSP
Device Problem Peeled/Delaminated (1454)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/18/2024
Event Type  Injury  
Event Description
When vassallo gt.014 xsp (the product) was advanced in combination with the phoenix atherectomy system, there was resistance.While attempting to pull the product back and tried to re-advance, the product would not respond.The product was finally removed, and it was observed that the product had sheared off some coating.Although the exact location was unknown, the coating had peeled off at more distal end of the product.The procedure was completed removing the product from the patient's body and stopping bleeding with vascular closure device.
 
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Brand Name
VASSALLO GT
Type of Device
GUIDE WIRE
Manufacturer (Section D)
FILMECC CO., LTD.
1703 wakita-cho
moriyama-ku
nagoya-shi, aichi 463-0 024
JA  463-0024
MDR Report Key18764394
MDR Text Key336050015
Report Number3023139607-2024-00001
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/22/2024,02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVGT14300XSP
Device Lot Number230907R041
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2024
Distributor Facility Aware Date01/24/2024
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer02/23/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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