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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
Catalog Number AB35W04200135
Device Problem Burst Container or Vessel (1074)
Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Event Date 01/21/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Pertains to a nanocross elite device: during aortogram with right leg runoff and subsequent right popliteal artery thromboembolectomy. Disruption of an 0. 146 x 200 angioplasty balloon occurred with inability to remove the distal segment which was retained in the severely diseased and essentially previously occluded distal superficial femoral artery and above-knee popliteal artery. Quick cross catheter was advanced into popliteal artery. 35 guidewire exchanged out with a 0. 14 wire. A 4-200 0. 14 evercross balloon was used to further angioplasty the vessel. A balloon burst was reported. An evercross 4x150 was used to complete the procedure. A bolus angiography revealed superficial femoral artery patent, diffusely diseased with irregularities and evidence of focal areas of dissection. A 6x200 nanocross elite balloon was used to angioplasty the popliteal artery above the knee as well as distal superficial femoral artery. No resistance or excessive force was used. It was reported the balloon fractured, the balloon could not be deflated distally. It gradually slated but could not be removed. Further traction on the balloon catheter resulted in separation of the distal two thirds of the balloon catheter. A gooseneck snare was used in an attempt to remove the components without success. The balloon remained in patient, two days post procedure the patient underwent a right popliteal artery endarterectomy to remove retained. No further patient injury reported for this event.
 
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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 Key8361067
MDR Text Key136848462
Report Number2183870-2019-00086
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 Risk Manager
Type of Report Initial
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAB35W04200135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/22/2019 Patient Sequence Number: 1
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