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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,

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MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Thrombosis/Thrombus (4440)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: case series - coronary artery perforations and different methods of management. Case series - coronary artery perfo rations and different methods of management. Year: 2021 ref: issn: 0975-3583, 0976-2833. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted for reviewed titled: case series - coronary artery perforations and different methods of management. One nc sprinter balloon catheter and one 6f launcher ebu guide catheter was used in a procedure to treat a critical focal stenosis in the mid rca. The patient presented with non st elevation myocardial infarction (nstemi). Coronary angiogram showed significant double vessel disease, there was also a type 3 tortuous lad with mid segment 90% calcific stenosis. Right femoral 6f arterial access was taken. The vessel was cannulated with the 6f launcher catheter with 3. 5 curve. The lesion was wired with non-medtronic coronarywire. The lesion was predilated with a 2. 5 x 10 mm semi-compliant balloon at 14 atm. A 3 x 36 mm non medtronic drug eluting stent was deployed at 12 atm. The non-medtronic stent was post dilated using a 3 x 10 mm sprinter non-compliant balloon 1:1 at 20 atm. The control angiography after post dilatation showed ellis type iii perforation at the distal edge of the stent. The nc sprinter balloon which was in the guide catheter was reintroduced immediately to the site of perforation and balloon occlusi on at 6 atmospheric pressure (atm) was done to seal the perforation. Echocardiography showed moderate pericardial effusion with right atrial diastolic collapse suggestive of tamponade. The patient experienced hemodynamic instability with a fall in blood pressure. Urgent pericardiocentesis was done with auto-transfusion of blood into the femoral venous access site; hemodynamics stabilised. Intermittent balloon occlusion at the site of perforation was continued for 20 minutes. Dual guide access strategy was planned as deflation of balloon for even a short span of time was causing fluctuation in hemodynamics. An alternate 7 french left femoral arterial access was taken. A non medtronic 7f guide was introduced. The existing launcher catheter was disengaged from left main coronary artery while the balloon was kept inflated in the lesion. The 7f catheter was positioned parallel to the first catheter and was used to cannulate the left coronary artery. A non medtronic guide wire was advanced until the proximal part of the inflated balloon. Just before it had to cross the site of perforation, the sealing balloon was deflated quickly. The guide wire was then crossed to the distal vessel. The nc sprinter was re-inflated. A 2. 8 x 26 mm non medtronic stent was then deployed at 17 atm. Imaging showed sealing of perforation. However there was a thrombus in ostial lad and lcx. Lcx was wired and thrombus aspiration done. The patient was stabilised in cardiac careunit. Dual antiplatelet therapy with aspirin and ticagrelor were continued. Angiogram on day 3 showed resolution of thrombus. The patient was discharged on day 6 in a stable condition.
 
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Brand NameNC SPRINTER RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
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 
EI  
091708734
MDR Report Key12630489
MDR Text Key276362044
Report Number9612164-2021-03938
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
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: 10/14/2021 Patient Sequence Number: 1
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