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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 AB35W12040080
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/31/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluation summary: sanguine residue was noted within the inflation lumen port of the y-manifold of the returned evercross dilatation catheter. The proximal end of the balloon chamber exhibited radial and longitudinal tearing. The inner guidewire lumen exhibited a separation face at the distal end of the balloon chamber¿s proximal marker band. The inner guidewire lumen exhibited longitudinal stretching just proximal of the proximal edge of the proximal radiopaque marker band, (the distance between the parallel light reflections narrows down). The distal edge of the radiopaque marker exhibits an oval shape. Only approximately 76. 3cm of the catheter distal of the y-manifold¿s printed strain relief was returned for evaluation. Over 40mm of balloon chamber length and inner guidewire lumen were not returned. The distal marker band and distal tip were not returned. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used an evercoss pta balloon with a 7fr sheath and an unknown guidewire for the treatment of an unknown lesion type in the iliac vein (diameter 12mm). Embolic protection was not used. The ifu was followed and device was prepped without issue. The balloon was inflated using an unknown inflation device with a contrast/saline fluid to a pressure of 8 atm. It was reported that a break occurred at the sheath during removal. The detached portion remains in the patient. It is unknown if resistance was encountered or if excessive force was used. In order to complete the procedure, the remaining balloon fragment was stented over within the vessel (unknown size stent used). 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 Key6840177
MDR Text Key100525678
Report Number2183870-2017-00369
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 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2020
Device Catalogue NumberAB35W12040080
Device Lot NumberA419491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
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: 09/01/2017 Patient Sequence Number: 1
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