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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-CV-GWY-AMPH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 11/23/2017
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a revascularization, an in. Pact deb paclitaxel balloon catheter was used to treat the target lesion (prox and mid sfa). During a second revascularization, two pacific plus balloon catheters were used to treat non-target lesions(distal sfa and pop1). Same day, a pacific plus balloon catheter was also used to treat the target lesion. During a third revascularization, an in. Pact pacific paclitaxel eluting balloon catheter was used to treat the target lesion. During a fourth revascularization, an amphirion deep was used to treat a non-target lesion. Approximately 19 months post first revascularization, 10 months post second revascularization, 7 months post third revascularization and 2 weeks post fourth revascularization, patient suffered hypoxia which was treated with medication. Patient died later on the same day. Investigator assessed event is not related to the index device, procedure or paclitaxel.
 
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Brand NameAMPHIRION DEEP PTA BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7590452
MDR Text Key110700352
Report Number9612164-2018-01403
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K052791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK-CV-GWY-AMPH
Device Catalogue NumberUNK-CV-GWY-AMPH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/12/2018 Patient Sequence Number: 1
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