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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INC SPRINTER OTW ANGIOPLASTY BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY
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MEDTRONIC INC SPRINTER OTW ANGIOPLASTY BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY Back to Search Results
Model Number 1.5MM X 12MM OTW BALLOON
Device Problem Material Rupture (1546)
Patient Problems Calcium Deposits/Calcification (1758); Device Embedded In Tissue or Plaque (3165)
Event Date 06/20/2019
Event Type  malfunction  
Event Description
Pt had heavily calcified left coronary system.The 1.5 x 12 mm sprinter balloon was advanced over the 0.14 coronary wire.The sprinter balloon was then used to pre-dilate in the first obtuse marginal.However, this was complicated by balloon rupture and fragmentation.Multiple attempts were unsuccessful in freeing the retained portion of the trapped balloon.Ultimately the fragment was stented against the wall of the heavily calcified vessel.The vessel was re-vascularized.Patient did well and discharged to home.
 
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Brand Name
SPRINTER OTW ANGIOPLASTY BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY
Manufacturer (Section D)
MEDTRONIC INC
8200 coral sea st ne # mvs74
moundsview MN 55112
MDR Report Key8798040
MDR Text Key151305475
Report Number8798040
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1.5MM X 12MM OTW BALLOON
Device Catalogue NumberSPR1512W
Device Lot Number216680462
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2019
Event Location Hospital
Date Report to Manufacturer07/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age29565 DA
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