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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB14W050200150
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Physician intended to use a nanocross elite pta balloon during treatment of a calcified lesion in the patient¿s superficial femoral artery (sfa). Moderate vessel calcification is reported. Artery diameter reported as 5mm. A 0. 014 guidewire was used. There was no damage noted to the product packaging prior to use. Ifu was followed and the device was prepped without issue. The device was passed through a previously deployed stent for post dilation. It is reported that a balloon burst occurred during inflation at a pressure of 14atm. It is reported the balloon could not deflate. The balloon could not deflate, so the physician used negative pressure. The balloon took 15 minutes to deflate, as it was a long and tough cto and the distal end got stuck and caught in the sheath. Two additional nanocross elite pta balloons which were prepped as per ifu were attempted to be used but could not be deflated at the lesion site. All components of all devices were removed from the patient with no intervention required. The deflation issues are reported to have caused thrombosis. No further injury reported.

 
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Brand NameNANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key10974796
MDR Text Key220402540
Report Number2183870-2020-00430
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAB14W050200150
Device Catalogue NumberAB14W050200150
Device LOT NumberB025619
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/08/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/09/2020 Patient Sequence Number: 1
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