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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER
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STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 6F X 110CM
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Perforation of Vessels (2135)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.
 
Event Description
The first case was ipsi-lateral and accessed the right cfa.We were working through a 6fr terumo short sheath.Patient had isr, wire placement was confirmed under ivus.Setup of device was performed - no problems.During use rtx the wire came back into the catheter quickly.Dr.(b)(6) performed an angiogram and noted a perforation of distal sfa.Covered stent was placed and patient was fine.
 
Manufacturer Narrative
Summary evaluation report attached.Added data to d8 and d9 and correction of initial reporter.
 
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Brand Name
ROTAREXS 6F 110CM (STRAUB MEDICAL)
Type of Device
ATHERECTOMY CATHETER
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ  7323
MDR Report Key10240506
MDR Text Key198520277
Report Number3008439199-2020-00017
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810575
UDI-Public7640142810575
Combination Product (y/n)N
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSET ROTAREX®S 6F X 110CM
Device Catalogue Number80236
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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