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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number SPL25020X
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems Intimal Dissection (1333); Fever (1858); Chest Tightness/Pressure (2463)
Event Date 03/19/2019
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 a sprinter legend rx ptca balloon catheter to treat a non-tortuous, mildly calcified lesion exhibiting 80% stenosis located in the mid left anterior descending (lad) artery. The device was inspected with no issues noted. Negative prep was performed without issue. The lesion was pre-dilated. Resistance was not encountered when advancing the device and excessive force was not used during delivery. It was reported that balloon deflation difficulties were experienced. The device was slow to deflate at the lesion site and could not be removed through the catheter. Repeated attempts were made to remove the device, resulting in a slight tear in the inner wall of the vessel. It was reported that the heartbeat and blood pressure of the patient were noted to be abnormal during the procedure and it is indicated that the patient felt unwell. After the procedure it was reported that the patient had a fever which resolved after two days. The patient is reported to be alive with no further injury.
 
Manufacturer Narrative
Additional information:no abnormal blood pressure noted. It is stated that difficulties were noted when removing the protective sheath. No difficulties were noted removing the packaging stylette. No difficulties noted during inflation. The deflation difficulties were encountered after the first inflation. The deflation time was at least 5 minutes. Various methods were used to deflate the balloon including pumping with a syringe. Finally, when the balloon was filled with contrast slightly less, the catheter was pulled out together with the guiding catheter, and the balloon was still filled with contrast after being pulled out. The patient had chest tightness and chest pain. 1:1 ratio contrast / saline was used. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation summary: the balloon returned fully deflated. There was no deformation to the balloon material. Stretching was evident to the material at the balloon bond causing a narrowing of the inflation lumen material. It was not possible to inflate the device to perform deflation testing due to the stretching on the material at the balloon bond. There was slight deformation to the distal shaft and inner member. There was no deformation to the distal tip. The sheath and stylette were not returned with the device. Image review summary: an image of the complaint device was received for analysis. The image shows the luer of the device, the balloon and a portion of the hypotube and distal shaft. There is no deformation to the device visible in the image. The lot number on the luer matches what was reported. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSPRINTER LEGEND 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 Key8455017
MDR Text Key139955515
Report Number9612164-2019-01053
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/16/2021
Device Catalogue NumberSPL25020X
Device Lot Number216420172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2018
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: 03/27/2019 Patient Sequence Number: 1
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