• 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
Catalog Number NCSP27515X
Device Problem Burst Container or Vessel (1074)
Patient Problems Occlusion (1984); Thrombus (2101); No Consequences Or Impact To Patient (2199); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 08/04/2020
Event Type  malfunction  
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 ptc balloon catheter to treat a non-tortuous, non-calcified lesion located in the mid/proximal left anterior descending (lad) artery. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was pre-dilated. The device did pass through a previously deployed stent. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It was reported that the balloon burst during balloon inflation at 20 atms. The patient was reported to be alive with no 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 Key10377813
MDR Text Key202032133
Report Number9612164-2020-02902
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSN
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 09/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2021
Device Catalogue NumberNCSP27515X
Device Lot Number218902153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2019
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: 08/07/2020 Patient Sequence Number: 1
-
-