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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO SPRINTER LEGEND OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number SPL12510WL
Device Problem Burst Container or Vessel (1074)
Patient Problems Occlusion (1984); No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use one sprinter legend otw ptca balloon catheter to treat a lesion in the lad. It was reported that a balloon rupture occurred.
 
Manufacturer Narrative
The target lesion was moderately calcified. The balloon was inspected and negative prep was performed prior to use with no issue noted. There was some degree of resistance in advancing the balloon catheter across the lesion. Excessive force was not used. The balloon rupture occurred during first inflation at nominal pressure. The device was not moved or repositioned in the lesion prior to the rupture. Blood was noted in the indeflator when device when placed on negative pressure. Dissection of the lad was noted after the inflation. Loss of flow was noted and the decision was made to place an iabp and send the patient to the or for bypass, given that the lesion could not be dilated. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSPRINTER LEGEND OTW
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 Key8105592
MDR Text Key128403743
Report Number9612164-2018-03366
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/03/2021
Device Catalogue NumberSPL12510WL
Device Lot Number215588453
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 Received01/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/04/2018
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: 11/27/2018 Patient Sequence Number: 1
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