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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number EUP2015X
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the procedure an attempt was made to use one sc euphora rx ptca balloon catheter to treat a lesion. The device was inspected with no issues noted. The lesion was not pre dilated. The device did not pass through a previously-deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used. It was reported that balloon deflation difficulties occurred and the balloon would not deflate at the lesion site. The balloon was inflated above the rbp until it burst. The patient was unharmed.
 
Manufacturer Narrative
Product analysis summary: a kink was evident on the hypotube 24cm distal to the strain relief. The device returned deflated. A portion of the balloon bond and the material immediately proximal to the proximal balloon bond appeared to have inflated. Stretching was evident to the balloon bond. The device was inflated to nominal pressure of 8 atm. The balloon, a section of the proximal balloon bond and the inflation lumen immediately proximal to the proximal balloon bond appeared to have inflated. The balloon appeared to be curved. An attempt was made to perform deflation testing however the balloon burst, therefore deflation testing could not be completed. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Add info: no difficulties were noted when removing the protective sheath and stylette. No difficulties were noted during inflation of the device. The device was not moved or repositioned prior to the deflation difficulties. The deflation difficulties occurred after first inflation. 50/50 concentration of contrast / saline was used. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameEUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8259946
MDR Text Key133462835
Report Number9612164-2019-00228
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/02/2020
Device Catalogue NumberEUP2015X
Device Lot Number216324969
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/03/2018
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: 01/18/2019 Patient Sequence Number: 1
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