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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP NANOCROSS¿ ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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COVIDIEN LP NANOCROSS¿ ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB14W050200150
Device Problems Material Rupture (1546); Sticking (1597)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/07/2017
Event Type  malfunction  
Event Description
Atherectomy of the proximal superior femoral artery (sfa) to the mid sfa done, but there was difficulty crossing the distal capsule so a four mm balloon angioplasty was performed.Then a five mm balloon was inflated into the mid sfa and into the proximal sfa, but upon inflation in the proximal, the balloon ruptured.Tried to retrieve the balloon, but it was stuck over the wire and then the hypotube slipped from the balloon shaft itself.There were multiple maneuvers to externalize the shaft balloon but it was stuck on the wire.It was pulled but a tiny part of the balloon was stuck into the right common iliac artery.
 
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Brand Name
NANOCROSS¿ ELITE
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN LP
4600 nathan lane north
plymouth MN 55442
MDR Report Key6696919
MDR Text Key79463981
Report Number6696919
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 User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/05/2019
Device Model NumberAB14W050200150
Device Catalogue NumberAB14W050200150
Device Lot NumberA355223
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
THE PATIENT WAS HAVING A COMPLEX CATH PROCEDURE US
Patient Age68 YR
Patient Weight64
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