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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 NCSP2515X
Device Problem Material Deformation (2976)
Patient Problem Intimal Dissection (1333)
Event Date 10/19/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: the transition tubing was stretched for distal to the transition bond. The distal shaft was severely deformed and kinked in numerous places distal to the guidewire entry port and extending along the shaft. The balloon folds were open and residue was present inside the balloon indicating that the device had previously been inflated. Approximately 0. 55cm of the inflation lumen material appeared to be inflated immediately proximal to the balloon bond. Upon pressurisation of the device, the inflation lumen material burst at 6atm. Image review: the images capture the mid rca lesion site as reported by the account. The images show the pre-dilation of the lesion site and the subsequent deployment of a stent in the mid-rca. A post dilation balloon was introduced into the distal end of the newly deployed stent. Inflation of this balloon was not shown on the images. There were no abnormalities noted in vessel post removal of the post dilation balloon. Images confirm the positioning and deployment of a second stent in the proximal rca overlapping with the mid rca stent. There was no evidence of post dilatation balloon issues or vessel damage post deployed of the proximal stent. Com: (b)(4). Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. 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
The procedure was prompted by coronary heart disease. It was reported that the physician was using a nc sprinter balloon to post dilate a stent that was implanted in the mid rca. The lesion exhibited 80% stenosis, no tortuosity. The nc sprinter balloon was inspected prior to use, with no issues noted. Negative prep was performed successfully prior to use. The balloon was inflated to 12 atms. After post dilation it was reported that blood vessels at the proximal end of the stent were dilated. The angiograph agent was retained. It was reported that it caused damage to good vessels in the right coronary artery which led to a vascular dissection. After retrieving the balloon from the patient's body, it was noted that there was something like a balloon at the proximal end of the balloon. The doctor implanted a resolute drug-eluting stent on the proximal dissection to complete the procedure. The patient reported as safe and remains in hospital.
 
Manufacturer Narrative
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.
 
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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 Key6121034
MDR Text Key100958730
Report Number9612164-2016-01181
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 11/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2018
Device Catalogue NumberNCSP2515X
Device Lot Number210469981
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2015
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: 11/22/2016 Patient Sequence Number: 1
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