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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC MEXICO ADMIRAL XTREME US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number ADM070040080
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/01/2017
Event Type  Injury  
Event Description
The physician intended to use the admiral xtreme pta to treat the right iliac artery. It was reported the balloon was advanced to the lesion, and inflated across the right iliac lesion at 8 atmospheres for 60 seconds. During the second inflation after 3 minutes the balloon ruptured at nominal pressure. The balloon was removed over a wire, it was observed after removal that a fragment of the balloon was caught at the sheath. The physician pulled the sheath slightly back and with a blade cut down and with hemostats retrieved the fragmented balloon piece. The sheath was advanced back and held pressure. The site continued to bleed the physician upsized the sheath from a 5f,6f,7f,8f to a 9f sheath and applied pressure. The sight stopped bleeding with no further issues reported.
 
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Brand NameADMIRAL XTREME US
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6926171
MDR Text Key88926407
Report Number9612164-2017-01419
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberADM070040080
Device Lot Number211990358
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 Received09/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/22/2016
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: 10/07/2017 Patient Sequence Number: 1
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