• 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 SPRINTER 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 SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number NCSP3021X
Device Problems Deflation Problem (1149); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); Insufficient Information (4580)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure, an attempt was made to use one nc sprinter rx ptca balloon catheter to treat a lesion. The device was inspected with no issues noted. Negative prep was performed with no issues noted. It was reported that the hub of the nc sprinter balloon cracked when attempting to inflate the device. The balloon was deflated using a 10cc syringe and the device was removed from the patient. The patient was reported to be alive with no further injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10470903
MDR Text Key204950531
Report Number9612164-2020-03230
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2021
Device Model NumberNCSP3021X
Device Lot Number218702038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2019
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: 08/31/2020 Patient Sequence Number: 1
-
-