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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO SOLARICE RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SLC2520X
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A solarice rx ptca balloon catheter was used during a procedure to treat a severely calcified lesion. It was reported that the balloon burst at 14atm. There is no patient injury reported.
 
Manufacturer Narrative
Additional information: the device was being used to treat a mildly tortuous, moderately calcified lesion with 75% stenosis in the mid right coronary artery (rca). The device was inspected before use with no issues noted. Negative prep was performed with no issues noted. The lesion was pre-dilated with the same balloon at 8-10 atm. No resistance was noted when advancing the device to the lesion. Excessive force was not used. The device did not pass through a previously deployed stent. The device was not moved or re-positioned in the lesion while inflated. It was stated that the balloon was first inflated to 8-10 atm and was deflated. The balloon was then advanced further in the lesion and a second inflation was performed. There was a sudden drop in pressure noted on the inflation device the balloon burst occurred on second inflation at 14 atm. The patient was reported to be alive with no injury. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSOLARICE 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 Key10127251
MDR Text Key194306501
Report Number9612164-2020-02119
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2021
Device Model NumberSLC2520X
Device Catalogue NumberSLC2520X
Device Lot Number218795385
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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