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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 PCF050300130
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
Patient weight reported as (b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a pacific xtreme device with a 6fr sheath and 0. 018 wire during treatment of a 30 cm lesion in the patients right full superficial femoral artery (sfa) and popliteal arteries of diameter 5 mm. Severe calcification is reported but no tortuosity. Crossover procedure. Lesion exhibited 90-100% stenosis. Embolic protection was not used. No damage noted to device or packaging prior to use. Ifu was followed. Device prepped without issue. The device was not passed through a previously deployed stent. No resistance was felt during advancement and not excessive force was used. A manometer was used with 50/50 fluid for balloon inflation. It is reported that 2 twists were evident on the balloon. The device was replaced with another pacific xtreme to complete the procedure. No patient injury reported.
 
Manufacturer Narrative
Image review: a single photograph of a cine image was received for analysis. The image is of a pta device within a vessel. Two balloon twists are present in the pta device. Product analysis: the pacific xtreme pta balloon catheter was received for evaluation. Two zones of witness marks from inflation twists were noted in the balloon chamber material. The twisting / ¿candy wrapper¿ is located 97mm and 157mm proximal of the catheter¿s distal tip. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the twist occurred during first inflation of the balloon. The device was 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 Key8991157
MDR Text Key157373546
Report Number9612164-2019-03868
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
Report Date 11/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2022
Device Catalogue NumberPCF050300130
Device Lot Number217704600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2019
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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