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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number PCU070200130
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a pacific xtreme pta balloon during treatment of a 200mm fibrous lesion in the patient¿s distal right superficial femoral artery (sfa) and popliteal artery. Slight vessel tortuosity and moderate calcification are reported. Vessel diameter is reported 7mm. Lesion exhibited 80% stenosis. No damage noted to product packaging prior to use. No issues noted wen removing the device from the packaging. A 7fr non-medtronic sheath and nitrex wire were used. Ifu was followed and the device was prepped without issue. An inflation device with 50/50 inflation fluid was used. The device was passed through a previously deployed stent no resistance was encountered. It is reported when inflating the balloon at the lesion site at a pressure of 4atm a twist was noted. A rewrap issue was noted. The balloon was removed, and a second pacific xtreme was advanced the same way. Two twists were observed on the second balloon. The balloon was removed, and the procedure was completed using a nanocross balloon. No patient injury reported.
 
Manufacturer Narrative
Additional information: the device was fully deflate prior to the device being safely removed from the patient. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key9774120
MDR Text Key191867478
Report Number9612164-2020-00956
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU070200130
Device Catalogue NumberPCU070200130
Device Lot Number218557811
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2019
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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