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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC NANOCROSS 2.5MM X 120MM BALLOON; CATHETER, ANGIOGRAPHY, PERIPHERAL TRANSLUMINAL

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MEDTRONIC, INC. MEDTRONIC NANOCROSS 2.5MM X 120MM BALLOON; CATHETER, ANGIOGRAPHY, PERIPHERAL TRANSLUMINAL Back to Search Results
Lot Number A775677
Device Problems Entrapment of Device (1212); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
Event Type  Injury  
Event Description
Pt had surgical procedure during which a medtronic nanocross 2.5 mm x 120mm balloon ruptured during inflation and upon removal, the distal marker did not come out with the balloon.
 
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Brand Name
MEDTRONIC NANOCROSS 2.5MM X 120MM BALLOON
Type of Device
CATHETER, ANGIOGRAPHY, PERIPHERAL TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key8464494
MDR Text Key140490458
Report NumberMW5085315
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/30/2022
Device Lot NumberA775677
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/28/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age48 YR
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