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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Sepsis (2067); Heart Failure (2206); Patient Problem/Medical Problem (2688)
Event Date 07/14/2016
Event Type  Death  
Manufacturer Narrative

Date of death: based on date of article publication. Date of event: based on date of article publication journal of endovascular therapy. Sagepub. Com/journalspermissions. Nav. Doi: 10. 1177/1526602816659279 www. Jevt. Org. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A study was conducted with 36 patients, to investigate the clinical outcomes of endovascular therapy for upper extremity peripheral artery disease with critical hand ischemia. The patients were treated with an amphiprion deep balloon and non-medtronic devices. The 3 patients died within 30 days, during follow-up it was reported that the patients presented with finger amputation, 7 fingers on 5 limbs, 2 limb amputations above the wrist, incomplete wound healing and puncture site problems, 20 patients died 4 with heart failure, 4 with ventricular fibrillation, 3 sudden death, 8 patients died non-cardiovascular 1 sepsis, 4 pneumonia, 3 suffocation and 1 unknown cause.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameAMPHIRION DEEP PTA BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7851235
MDR Text Key119380511
Report Number3004066202-2018-00042
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK052791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received12/06/2018
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: 09/06/2018 Patient Sequence Number: 1
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