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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 AB35W06200135
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/11/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use an evercross pta balloon with a 6fr non-medtronic sheath and non-medtronic 0. 035 guidewire during treatment of a 250mm cto (chronic total occlusion-100%) in the patient¿s mid left superficial femoral artery (sfa). Vessel diameter reported as 6mm. Severe vessel calcification is reported. No damage noted to the product packaging prior to sue. No issues noted when removing the device from the packaging. Ifu was followed and the device was prepped without issue. A non-medtronic inflation device as used with 50/50 contrast and saline mix. The device was advanced through the 6fr sheath from contralateral access site over the non-medtronic 0. 035 wire to the target left sfa lesion. No resistance was encountered during advancement. The balloon was inflated once to dilate the lesion and was removed. A stent was then placed in the left sfa. The evercross was again advanced to post-dilate the stent. It is reported that the balloon ruptured on second inflation at a pressure of 8atm. Following the rupture, the balloon was removed from the patient. The physician then attempted to remove the detached fragments using a snare unsuccessfully. The patient was then transferred to a local hospital. It is reported fragments of the balloon remain in the patient¿s left sfa. No further 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 Key10166777
MDR Text Key195526997
Report Number2183870-2020-00178
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W06200135
Device Catalogue NumberAB35W06200135
Device Lot NumberB014503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/18/2020 Patient Sequence Number: 1
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