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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCSP27509X
Device Problem Burst Container or Vessel (1074)
Patient Problems Aneurysm (1708); Low Blood Pressure/ Hypotension (1914); Pain (1994); Perforation (2001); Cardiac Tamponade (2226); Patient Problem/Medical Problem (2688)
Event Date 05/25/2011
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). 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
It was reported that the physician was attempting to use a nc sprinter balloon during a procedure for post dilation following successful stenting of a single lesion. The device was prepped in the usual fashion and positioned close to distal edge of the previously deployed stent and inflator device connected. While screening to fine tune the balloon, it was noted that the balloon had already been deployed (to an unknown pressure) inadvertently. It was reported that the balloon ruptured and a distal edge dissection occurred in the left main coronary artery. There was an injury to a blood vessel and haemopericardium requiring stabilization and urgent review by anaesthetics and the cardio thoracic surgery team. The patient underwent urgent drainage of the pericardial effusion and coronary artery bypass grafting. During the emergency procedure, a primary median sternotomy was performed, the right pleura was opened. Vessels were harvested from the patients right leg, pericardium was opened and the effusion drained, estimated to compromise about 500mls of blood. The saphenous vein was grafted to the lad and marginal circumflex. The patient was discharged to intensive care for 12 days post event. The reported particulars of injury include an aneurysm at the site of the perforation, pain in the sternum and rib cage, hypotension, shock and trauma, pain and numbness in the left leg, nerve entrapment syndrome involving the left leg and distress.
 
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Brand NameNC SPRINTER 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 Key5658758
MDR Text Key100770011
Report Number9612164-2016-00461
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCSP27509X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/17/2016 Patient Sequence Number: 1
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