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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
Catalog Number PCF040250090
Device Problem Material Twisted/Bent (2981)
Patient Problem No Information (3190)
Event Date 05/06/2019
Event Type  malfunction  
Manufacturer Narrative
Image analysis: two photographs of cine images were received. The first image is of the inflated pacific xtreme inflated in the patient¿s mid right superficial femoral artery, towards the bottom of the image a section of the balloon is twisted ¿candy wrap¿. The second image is of the inflated pacific xtreme inflated in the patient¿s mid right superficial femoral artery, towards the top of the image a section of the balloon is twisted ¿candy wrap¿. The customer experience of the pacific xtreme balloon twisting when inflated in the targeted vessel anatomy was confirmed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a pacific xtreme device during treatment of a calcified/plaque lesion in the patients mid right superficial femoral artery (sfa). No tortuousity is reported. Moderate calcification is reported. The lesion exhibited 70% stenosis. Ifu was followed and the device was prepped without issue. An inflation device was used for balloon inflation. It was reported that a 'candy wrap' effect was noted. Due to experience the physician successfully completed the procedure using this device without any inconvenience to the patient.
 
Manufacturer Narrative
Device evaluation: the pacific xtreme was received within its shelf carton, within its opened labelled pouch, and loaded within its protective transportation hoop. The lot data information printed on the y-manifold is consistent with the lot number on the pouch, shelf carton, and reported event. Visual examination of the balloon chamber revealed ¿balloon twist¿ witness marks in the balloon chamber material. The ¿candy wrapper¿ ¿balloon twist¿ are located approximately 45mm and 80mm distal of the proximal balloon marker band. 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.
 
Manufacturer Narrative
Cine image review: images 1 and 2 appear to be from the same case and involve an implanted stent. The lesion proximal (towards the heart) to the stent appears to be tortuous and calcified. Image 3 has an arrow annotating the location of a balloon twist ¿candy wrapper¿. A stent is visible in the bottom third of the of the image and a guidewire runs the length of the image. Image 4 appears to be from the original case and has two arrows annotating the location of a balloon twist ¿candy wrappers¿. A guidewire runs the length of the image. Image 5 appears to be from the original case in this cine the pta balloon catheter appears to be fully inflated without balloon twists ¿candy wrappers¿. A guidewire runs the length of the image. Image 6 appears to have multiple stents deployed, at least three stents with two of them over lapping at the bottom of the cine. Images 7 and 8 appear to be from another case based on the anatomy land marks and may involve a drug eluting balloon based on the annotation at the top of the image. Analytical analysis of the additional cine received confirms the original analysis and investigation conducted. No changes to the findings or codes of the original analysis and investigation. 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 Key8882968
MDR Text Key153955300
Report Number9612164-2019-03329
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K103464
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,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberPCF040250090
Device Lot Number213411573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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