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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 AB35W06040080
Device Problems Burst Container or Vessel (1074); Stretched (1601); Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/08/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used an evercross balloon for distal superficial femoral artery (sfa)/popliteal artery (pa) percutaneous angioplasty procedure. The lesion was described as being heavily calcified. It is reported that the evercross balloon ruptured during inflation and broke off from the shaft as it was being removed through the vascular access sheath. The balloon is reported to have detached completely from its shaft and the inner core. The physician attempted to snare the detached portion "bit" this was unsuccessful initially. This snaring attempt resulted in straddling the puncture site. The physician was successful in pushing the detached portion into the sfa again and it was successfully snared in its entirety. No consequent damage on angiography or clinically, apart from mild groin haematoma. No pseudoaneurysm on uss. The remainder of the stenting procedure was completed without issue. Patient was informed and hospitalised overnight. No long-term injury was reported.
 
Manufacturer Narrative
Lot a579312 was originally reported. This lot number is not valid. The lot number associated with this event is unknown. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis: the evercross was returned. Two non-medtronic 6f sheaths were returned. One sheath showed a snare device loaded the introducer sheath. No other ancillary devices were included. The returned contents were inspected. One non-medtronic 6f sheath had no device loaded. Only the dilator. The second no-medtronic sheath showed a snare device inserted. The snare device had captured the distal end of the fractured catheter shaft and balloon. Approximately 4. 5cm of the fractured end was exposed outside of the distal rim of the sheath. The proximal end of the portion of the stent lodged inside the distal rim of the sheath showed the catheter shaft stretched proximally behind the proximal marker band. The stretched catheter shaft indicates a fracture due to exposure to excessive tensile force. The balloon material showed a radial burst. The end of the evercross was pulled out of the sheath in order to inspect the entire segment. The hoop of the snare captured the distal end of the catheter. The length of the segment after pulling from the sheath was approximately 6. 5cm. The distal and proximal marker bands were located on the catheter shaft. The proximal segment of the evercross was inspected. The approximate working length was 76cm. The distal end of the catheter showed the proximal bond of the balloon and the radial burst of the balloon. The catheter fracture face was straight. Working length per product labeling is 80 cm and the total length of both returned segments of the evercross was approximately 83. 5cm. The longer length is consistent with the observation make of stretching at the fracture location. 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 Key8099819
MDR Text Key128200447
Report Number2183870-2018-00529
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2021
Device Model NumberAB35W06040080
Device Catalogue NumberAB35W06040080
Device Lot NumberA661209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2018
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: 11/23/2018 Patient Sequence Number: 1
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