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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 AB35W04200135
Device Problem Leak/Splash (1354)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician was attempting to use an evercross balloon to treat a lesion in a right leg fem-pop bypass graft (sfa to pt). The device was inspected prior to use and prepped and flushed per the ifu. Negative prep was not performed. It was reported that the balloon was successfully delivered over a non-mdt guidewire to the lesion site. As the physician started to inflate the balloon with a non-mdt inflation device to an unknown pressure, contrast was noticed flowing past the balloon and into the vessel. No balloon expansion occurred. The balloon was then removed from the patient and inflated on the table - again, contrast leaked from the balloon. The physician used a new balloon to complete the procedure without further complication. The patient was treated with a tissue plasminogen activator(tpa) drip overnight. The physician reported that the patient presented with a clot initially. There was never any risk to the patient reported during this procedure.
 
Manufacturer Narrative
Evaluation summary: the evercross device was received for evaluation. No ancillary devices were included. The evercross was removed and inspected. Traces of clear fluid was noted within the balloon and blood was noted at the distal end of the balloon. No damages to the catheter shaft, manifold, or balloon assembly were observed. The device was front-loaded with a 0. 035" guidewire from the lab. An inflation device from the lab was filled with water & was connected to the balloon port of the manifold. At 1 atm a leak was observed at the distal end of the balloon. Upon inspection under microscope the leak originated from a pinhole between the distal end of the balloon and the distal marker band. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7435541
MDR Text Key105634755
Report Number2183870-2018-00230
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
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/10/2019
Device Model NumberAB35W04200135
Device Lot NumberA325292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2016
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: 04/17/2018 Patient Sequence Number: 1
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