• 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 SPRINTER LEGEND 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 SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SPL12510X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/21/2017
Event Type  Injury  
Event Description
It was reported that the physician was attempting to use a sprinter legend rx balloon to treat a severely calcified and mildly tortuous lad lesion exhibiting 90% stenosis.It was reported that the balloon tore / broke during removal of the balloon.The detached portion of the device remained in the patient's body.An attempt was made to remove the detached portion but attempt was unsuccessful.The patient was then transferred to the cardiac surgery department where removal of the fragment was planned by thoracotomy.
 
Manufacturer Narrative
Additional information: no issues were noted during device inspection prior to use.The balloon tore / broke in the coronary artery during removal of the balloon.Rather strong resistance was noted during withdrawal.The device was used in a normal manner.Deflation was confirmed before attempting to remove the device from the patient.The thoracotomy occurred on the same day.The detached portion was discarded.The sales rep reported that the patient was transferred to bypass surgery, but further information is not obtained regarding patient outcome.Evaluation summary: blood residue was visible through the distal shaft.Numerous kinks were evident on the hypotube.The device returned with a detachment on the distal shaft; 34cm distal to the guidewire entry port.The lumen material was badly stretched, and proximal side of the detachment site was jagged and uneven.Distal side of detachment side was not returned for analysis.Kinks were evident throughout the distal shaft; 4-10cm proximal to the detachment site.Cine image review two still cine images were provided by the account capturing the left coronary vessels.A guidewire is visible in the vessel.There appears to be a single radiopaque marker visible on the guidewire; this is possibly the detached portion of material from the sprinter legend device.However, this cannot be confirmed.The root cause of the material detachment could not be determined from the still images.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPRINTER LEGEND RX
Type of Device
CATHETERS, 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 Key6716855
MDR Text Key80142139
Report Number9612164-2017-00904
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial,Followup
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/27/2018
Device Model NumberSPL12510X
Device Catalogue NumberSPL12510X
Device Lot Number209650749
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/21/2017
Initial Date FDA Received07/17/2017
Supplement Dates Manufacturer Received08/16/2017
Supplement Dates FDA Received09/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-