• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCEUP2520X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/19/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made use an nc euphoria balloon catheter to pre-dilate a moderately tortuous, severely calcified lesion, with 80% proximal stenosis and 90% distal stenosis, in the mid-distal left-anterior descending artery. There was no damage noted to the device packaging. There were no issues noted when removing the device from the hoop. There was no difficulty removing either the outer protective sheath covering the balloon, or the stylette. The balloon was prepped in the hoop to activate the hydrophilic coating. The device was inspected with no issues noted. (b)(6) prep was performed with no issues. The lesion was pre-dilated. The device passed through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used. The device was not kinked or re-straightened during use. The balloon would not inflate. It is reported that a portion of the catheter detached during delivery through the vessel. The catheter was completely separated into two pieces at the site of balloon shaft fracture. This was noted as the balloon was being withdrawn from the patient via the sheath and only the proximal segment came out. The remaining distal segment was then visualized with fluoroscopy to confirm it¿s presence still in the body and it¿s location. The detached portion does not remain in the patient. Another nc euphorias device (2. 0x20mm) was inflated to low pressure was used to trap the fractured catheter inside a 6f non-mdt catheter that was being used during the case. The 6f non-mdt catheter, the fractured balloon catheter and additional balloon were then removed from the body as a single unit with no complications. No patient injury is reported.
 
Manufacturer Narrative
Evaluation summary: the device returned with a detachment on the hypotube 48. 5cm distal to the strain relief. The hypotube material was oval and jagged on both sides of the detachment site. Kinks were evident on the hypotube 0. 5cm , 2. 5cm and 14cm proximal to the detachment site. It was not possible to perform inflation testing due to the detachment. There was no stretching to the balloon bonds. There was damage to the guide wire entry port. No other damage visible to the distal shaft. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7432115
MDR Text Key105509839
Report Number9612164-2018-00798
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141090
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 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/23/2019
Device Catalogue NumberNCEUP2520X
Device Lot Number213895287
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2017
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: 04/16/2018 Patient Sequence Number: 1
-
-