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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK-CV-GWY-PCP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)
Event Date 06/02/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During revascularization of the target lesion a pacific plus pta and four in. Pact pacific paclitaxel eluting balloon catheters were used. During a second revascularisation of the target lesion an amphirion deep pta and an in. Pact pacific paclitaxel eluting balloon catheter were used. During a third revascularization of the target lesion, an admiral xtreme pta and an in. Pact pacific paclitaxel eluting balloon catheter were used. During a fourth revascularization of the target lesion an amphirion deep pta and two in. Pact pacific paclitaxel eluting balloon catheters were used. Approximately 21 months post first revascularization, 16 months post second revascularization, 13 months post third revascularization and 8 months post fourth revascularization patient suffered re occlusion of the left sfa and popliteal (target lesion) and was treated with surgical intervention (bypass). Patient recovered.
 
Manufacturer Narrative
The surgical intervention (bypass) was performed approx 5 days post the occlusion event. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Following bypass surgery, the lesion occluded. The patient was further treated approximately five months later with deb to the left sfa. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
av.paseo del cucapah #10510
tijuana,bc 22570
MX 22570
MDR Report Key7529001
MDR Text Key108722019
Report Number3004066202-2018-00025
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK-CV-GWY-PCP
Device Catalogue NumberUNK-CV-GWY-PCP
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/21/2018 Patient Sequence Number: 1
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