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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 ROTAREX®S 6F X 110CM
Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
Suspect device not returned yet.The return of suspect device is expected.
 
Event Description
The rotarex catheter tip broke on withdrawal after 2 passes for thrombectomy of occluded left sfa/pop stents and was retained in patient's left sfa.Patient required additional cut down, arteriotomy and repair of the right common femoral artery.The catheter broken tip was snared back to right femoral and was removed via an open cutdown.
 
Manufacturer Narrative
Summary evaluation report attached.
 
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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 Key10694510
MDR Text Key211869059
Report Number3008439199-2020-00048
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 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model NumberROTAREX®S 6F X 110CM
Device Catalogue Number80219
Device Lot Number200840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Date Manufacturer Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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