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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER

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STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 6F X 135CM
Device Problems Break (1069); Fracture (1260)
Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)
Event Date 11/27/2020
Event Type  Injury  
Manufacturer Narrative
Evaluation protocol not completed yet.
 
Event Description
Rotarex came apart inside patient. Had to remove catheter using endovascular tricks. No patient harm. 6 fr guiding catheter was used to trap the broken helix and subsequently a 2 x 12 coronary balloon was used to trap the helix into the catheter which was then retracted from the patient's body without incident. Once the broken helix was retracted we then angioplasty with both poba and dcb. We then noticed a non-flow limiting dissection in the mid sfa which we tacked up with a 6 x 1 50 mm lifestent. Angiography revealed a good result and the case was completed without further incident.
 
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Brand NameROTAREXS 6F 135CM (STRAUB MEDICAL)
Type of DeviceATHERECTOMY CATHETER
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ 7323
Manufacturer (Section G)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ 7323
Manufacturer Contact
martin kvokacka
straubstrasse 12
wangs, sankt gallen 7323
SZ   7323
MDR Report Key11046337
MDR Text Key222663400
Report Number3008439199-2020-00072
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSET ROTAREX®S 6F X 135CM
Device Catalogue Number80237
Device Lot Number200772
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Yes
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: 12/21/2020 Patient Sequence Number: 1
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