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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC IRELAND SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SPR2506W
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Injury (2348); Insufficient Information (4580)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A sprinter otw ptca balloon catheter was used during a procedure. There was no issue removing the device from the hoop. Negative prep was not performed. The device did not pass through a previously deployed stent. Resistance was not encountered. Excessive force was not used. It was reported that nine days after the procedure the patient had ohca. Emergency cag showed an obstruction in the lad. Oct revealed a tube-like structure. Control angiography 5 days later showed persistent image despite antithrombotic therapy. The patient went for surgery (morrow procedure) due to sever residual lvot obstruction. In that surgical procedure the surgeon removed the sleeve in the lad, which explains the image and clinical follow-up after the initial alcohol ablation. Standard procedure about unwrapping the device was not followed. Therefore sleeve may not have been removed. The patient is alive with no further injury.
 
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Brand NameSPRINTER OTW
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10605587
MDR Text Key209136314
Report Number9612164-2020-03697
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPR2506W
Device Catalogue NumberSPR2506W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/30/2020 Patient Sequence Number: 1
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