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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number SBI070040080
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/28/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluation summary: the device returned for evaluation. The information provided on the luer and label are consistent with the complaint form report. The device was full of hardened blood and broken in pieces. A visual and a tactile inspection was carried out on the device with the following results: the balloon broke at approximately 2 cm from the proximal balloon welding; the distal part of the balloon was missing together with distal marker; the guidewire lumen underneath the balloon was stretched. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was treating a little calcified lesion in the right sfa using admiral xtreme balloon catheter. The device was intended to pre-dilate the vessel. It was reported that the balloon burst at 20atm during balloon inflation. After burst of the balloon, it was difficult to retrieve the balloon through the sheath. Force was required to get it back out of the sheath, then the marker was noticed on the wire and could not be retrieved into the sheath. A snare was needed to remove wire with marker. Balloon came back out of the sheath in several parts. All fragments of the balloon were retrieved from the patient. Excessive force was used during withdrawal. Extra sheath was placed in the contra lateral groin. The vessel was non-tortuous, with 80% lesion stenosis, vessel diameter 7mm and lesion length 20mm. There was resistance encountered when advancing the device and device did not pass through a previously deployed stent. There was no damage on packaging and no issues noted when removing device from hoop. The device was prepped per ifu with no issues identified. There were no clinical sequelae reported.
 
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Brand NameADMIRAL XTREME OTW
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 Key6985098
MDR Text Key101161407
Report Number9612164-2017-01511
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K062809
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 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberSBI070040080
Device Lot Number213556754
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2017
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: 10/27/2017 Patient Sequence Number: 1
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