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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA REEF HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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INVATEC SPA REEF HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number REU050040052
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a reef hp pta balloon catheter during procedure to treat a moderaterly calcified lesion in the proximal elbow head vein with 70% stenosis. The vessel diameter and lesion length are 4mm and 40mm respectively. There was no damage noted to packaging and no issues noted when removing device from hoop/tray. The device was inspected with no issues noted. The device was prepped with no issues noted. It was reported that during balloon inflation, at first expansion, the balloon burst at 18atm. It was reported that there was problems with stress during the first expansion. There was no patient injury reported.
 
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Brand NameREEF HP
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9450333
MDR Text Key194321649
Report Number3004066202-2019-00058
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/11/2020
Device Catalogue NumberREU050040052
Device Lot Number1I003340
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 Received01/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2017
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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