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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 Break (1069); Fracture (1260)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation protocol not completed yet.
 
Event Description
The catheter was found broken when doctor tried to remove it for flushing purpose when the catheter was no longer moving under fluoroscopy.The tip of the catheter was broken and she has to snare it out from patient's body.
 
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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 Key10841131
MDR Text Key217702324
Report Number3008439199-2020-00059
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810285
UDI-Public7640142810285
Combination Product (y/n)N
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model NumberSET ROTAREX®S 6F X 110CM
Device Catalogue Number80219
Device Lot Number200840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Initial Date Manufacturer Received 10/16/2020
Initial Date FDA Received11/14/2020
Supplement Dates Manufacturer Received10/16/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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