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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 AMD020150152
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 06/07/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician attempted to use an amphiprion deep balloon to treat a calcified, fibrous, plaque lesion in the distal anterior tibial artery. The vessel was reported as moderately tortuous and calcified with chronic total occlusion of 100%. The artery was 3mm in diameter. There were no abnormalities reported in relation to anatomy. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. There were no issues noted when removing the device from the hoop/tray. The device was not prepped per the ifu. The device did not pass through a previously-deployed stent. No resistance was encountered when advancing the device. No excessive force used. Embolic protection was not used. The balloon was inflated with a syringe. A 6 sheath and non medtronic guidewire was used. After the guide wire was in place it was expanded with 2. 0 deep. It is reported that it was very difficult to withdraw the balloon after it was filled, and the process of filling was not smooth. Relatively long time to deflate the balloon. Intervention required to remove. When going out of the sheath, it was necessary to manually arrange the balloon removal under negative pressure. The device was remo ved safely. No vessel damage noted. There were no patient symptoms or complications associated with this event.
 
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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 Key12058225
MDR Text Key258065949
Report Number9612164-2021-02473
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 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAMD020150152
Device Lot Number221023881
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2020
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: 06/24/2021 Patient Sequence Number: 1
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