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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 EUP22515X
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one euphora rx ptca balloon catheter to treat a non-tortuous, non-calcified lesion exhibiting 70% stenosis located in the mid/proximal right coronary artery (rca). The device was inspected with no issues noted. Negative prep was performed with no issues noted. The lesion was 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 during delivery. It was reported that a balloon burst/leak occurred during the second balloon inflation at 12 atm. No medical or surgical intervention was required to prevent a permanent impairment of a function. The event did not lead or extend patient hospitalisation. The patient was reported to be alive with no injury.
 
Manufacturer Narrative
Additional information: relevant medical history added. 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 Key10100318
MDR Text Key193063014
Report Number9612164-2020-02021
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
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 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2021
Device Catalogue NumberEUP22515X
Device Lot Number217189547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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