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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number SBI060120080
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use an admiral xtreme pta balloon during patient treatment. The treated vessel was described as non calcified and non tortuous. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. There were no issues noted when removing the device from the hoop/tray. The device was prepped with no issues identified. The device did not pass through a previously-deployed stent. No resistance was encountered when advancing the device and no excessive force was used. It is reported a burst occurred on the balloon during inflation. A dcb was used to complete the procedure. No patient injury reported.
 
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Brand NameADMIRAL XTREME OTW
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14235648
MDR Text Key290265766
Report Number9612164-2022-01615
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K173515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSBI060120080
Device Lot Number222111899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/20/2021
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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