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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 Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 11/21/2017
Event Type  Injury  
Manufacturer Narrative
A compliant balloon and a 2. 75mm nc sprinter had been already used. (compliant balloon did not open fully, nc sprinter device broke and a new device was then introduced). Lot details updated. Product analysis: a 0. 014inch guidewire was returned loaded in device. It was not possible to remove gw from device during analysis. The device was returned with blood visible in the balloon and inflation lumen. The balloon had torn in a radial pattern with 7mm of balloon material present distal to the proximal bond. The remaining balloon material and a section of the distal tip had detached. The balloon and tip material was jagged and uneven at the detachment site. Visual inspection confirmed only one marker remained on the inner shaft. 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 an nc sprinter balloon to pre-dilate a moderately calcified mid rca lesion. No damage was noted to the nc sprinter's packaging and no issues were noted when removing the device from the hoop/tray. The device was inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. During the procedure, the device did not pass through a previously deployed stent. No resistance was encountered and no excessive force used during delivery. It was reported that the balloon was expanded slowly, at an atm of 18-20. The balloon burst on the 1st inflation. When the balloon was pulled out, the distal marker became unfastened and stayed in the mid rca. The physician attempted to rewire the vessel using a non-medtronic wire but could not remove the distal part of the marker from the vessel. The physician then measured acceptable timi iii flow in the vessel so no further intervention was attempted.
 
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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 Key7205873
MDR Text Key101987374
Report Number9612164-2018-00104
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFI
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 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/22/2019
Device Catalogue NumberNCSP27509X
Device Lot Number212999171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2017
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: 01/19/2018 Patient Sequence Number: 1
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