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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO AMPHIRION DEEP OTW CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number AMD020120152
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use an amphirion deep pta balloon during treatment of a calcified and plaque cto (chronic total occlusion-100%) in the patient¿s mid and distal left superficial femoral artery, posterior tibial artery, and anterior tibial artery. Slight vessel tortuosty and calcification are reported. There was no damage noted to the packaging. No issues noted when removing the device from the hoop/tray. Ifu was followed and the device was prepped without issue. A syringe was used for balloon inflation with normal saline: contrast agent, 1:1 ratio. The device was not passed through a previously deployed stent. No resistance was noted during advancement. Balloon inflation difficulties are reported. At 7atm it is reported that the balloon was slow to deflate at the lesion site. No pinhole noted. No kink noted to balloon or catheter, nor any other damage to balloon catheter noted. No intervention required to deflate balloon. Device was safely removed from patient. A replacement balloon was used to complete the procedure. No patient injury reported.
 
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Brand NameAMPHIRION DEEP OTW
Type of DeviceCATHETER, PERCUTANEOUS
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 
EI  
091708734
MDR Report Key11795883
MDR Text Key249724911
Report Number9612164-2021-01814
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAMD020120152
Device Lot Number220749200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2020
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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