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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
Catalog Number SLC3020X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Thrombus (2101)
Event Date 04/28/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). Device evaluation: device decontaminated with cidex-opa pending further device testing to support the final product analysis findings. The device returned with a detachment on the transition tubing immediately proximal to the guidewire entry port. The transition tubing material was uneven and jagged on both sides of the detachment site. The distal shaft was stretched, bunched and deformed. The support wire had torn through the transition tubing and the distal shaft. The balloon folds were open and blood was visible in the inflation lumen and balloon. There was slight damage to the distal tip. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was initially reported that a physician was attempting to treat a severely calcified, occluded lesion in the right ata using amphirion deep dilatation balloon catheter, it was reported that the balloon burst in the artery and detached/separated from the catheter. The procedure could not be completed, because the balloon must be recovered from the vessel. The balloon was attempted to be removed using a goose neck and whisper es guidewire but was not easy, in case of that thrombus was building up and the intervention was stopped. Patient was given heparin and bivalirudin for the thrombus and the patient is being monitored. The patient will come back another time. Device was inspected and prepped with no issues noted. No force was used during the procedure and no resistance was encountered when advancing the device. No further clinical sequelae were reported for this event. The device was returned to the manufacturing facility for evaluation but it was not an amphirion deep device used during the procedure. The device received for analysis was a solarice coronary balloon catheter.
 
Manufacturer Narrative
(b)(4).
 
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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 Key6002423
MDR Text Key100938992
Report Number9612164-2016-01025
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 09/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2018
Device Catalogue NumberSLC3020X
Device Lot Number210901022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2016
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: 10/06/2016 Patient Sequence Number: 1
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