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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCEUP4015X
Device Problem Burst Container or Vessel (1074)
Patient Problem Intimal Dissection (1333)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis: the device returned with balloon folds open and residue present inside the balloon indicating that it had already been inflated. The device failed negative prep. On pressurisation of the device, a leak was observed on the proximal section of the balloon. There was a short longitudinal tear on the proximal balloon working length. The balloon material was jagged, uneven and raised at the tear site. The distal shaft was kinked 8. 2cm distal to the guidewire entry port. There was deformation to the distal tip. Still cine image review: four still cine images were received. The first still cine images confirm the lesion site in the rca as reported by the account. The next images capture the inflation of the nc euphora balloon at the lesion site. The final image captures the guidewire and the two marker bands with what appears to be the burst balloon. There is no evidence of a dissection from the cine images. (b)(4).
 
Event Description
It was reported that the physician was attempting to use a nc euphora balloon. The target lesion was in the rca : tubular eccentric 80% ln of proximal rca, ulceration. No damage noted to device packaging. The device was inspected with no issues noted. Negative prep was performed with no issues noted. The device was being used to post-dilate a deployed 3. 5 x 23mm stent. It was reported that a balloon rupture occurred during a subsequent balloon inflation before rbp at 12 atm. When (b)(6) was done, a proximal edge dissection was noted. The device was not moved or repositioned prior to the burst. The physician completed the procedure with an unknown brand device. Patient status post procedure is alive - no injury.
 
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Brand NameNC EUPHORA 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 Key6154699
MDR Text Key101841909
Report Number9612164-2016-01236
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K141090
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 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/04/2018
Device Catalogue NumberNCEUP4015X
Device Lot Number210788995
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2016
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: 12/08/2016 Patient Sequence Number: 1
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