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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB35W04040135
Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Physician was attempting to use evercross pta balloon catheter during procedure to treat a moderately calcified lesion in the mid sfa with 70% stenosis. Negative prep was performed. An inflation device was used to inflate the balloon. There was no damage noted to packaging. The device was prepped per ifu with no issues identified. It was reported the balloon catheter did not go up along the wire. It was reported that during balloon inflation balloon burst occurred at an unknown atm. All balloon fragments of the balloon were retrieved. A new evercross pta balloon was used to complete the procedure. There was no patient injury reported.

 
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Brand NameEVERCROSS 035
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 
091708734
MDR Report Key9823275
MDR Text Key195302332
Report Number2183870-2020-00084
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAB35W04040135
Device Catalogue NumberAB35W04040135
Device LOT NumberA536044
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/26/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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