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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SPRINTER LEGEND RAPID EXCHANGE BALLOON CATHETER

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MEDTRONIC SPRINTER LEGEND RAPID EXCHANGE BALLOON CATHETER Back to Search Results
Model Number M724511B001
Device Problems Balloon (419); No Pressure (2994)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2015
Event Type  Malfunction  
Event Description

Balloon would not maintain pressure during inflation of rapid exchange dilatation catheter.

 
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Brand NameSPRINTER LEGEND
Type of DeviceRAPID EXCHANGE BALLOON CATHETER
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55432
MDR Report Key5330241
MDR Text Key34570253
Report NumberMW5058768
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NURSE
Type of Report Initial
Report Date 12/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL NumberM724511B001
Device Catalogue NumberSPL25020X
Device LOT Number208605820
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/22/2015 Patient Sequence Number: 1
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