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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 Fracture (1260); Patient-Device Incompatibility (2682)
Patient Problems Embolism (1829); Perforation of Vessels (2135); Great Vessel Perforation (2152); Foreign Body In Patient (2687); Vascular Dissection (3160)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative
Use of first device (previous one) during this procedure is described and investigated in 3008439199-2020-00021.
 
Event Description
Use of first (previous) device during this procedure is described and investigated in 3008439199-2020-00021. Dr. (b)(6) decided a second device was appropriate at this time. The 2nd device was run up and over without incident and down to the lesion. Again, after a minute or so, the clutch began to slip o rotarex. Dr. (b)(6) decided it would be appropriate to put a 4mm balloon down so he began removing the device. As he was removing, he noticed that the tip of rotarex was not moving with the catheter. He examined the catheter under flouro and we couldn't see if it was broken so he continued with trying to remove the device slowly. As he removed rotarex, he was not feeling any resistance and it was determined the helix was no longer attached. He was able to snare the helix in an attempt to pull it out through the sheath. Dr. (b)(6) was able to get the tip pulled back up to the right cfa before the patient complained of discomfort in his right groin area. At that time dr. (b)(6) decided to do a cut down of the right cfa to remove the helix. When dr. (b)(6) got to the helix he said it still felt stuck and was not coming out easily. At that time it was determined there was a perforation at the bifurcation and he opened the patient up. Dr. (b)(6) was able to retrieve the device after cutting it in half. Patient is in stable condition as of this morning.
 
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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 Key10319635
MDR Text Key207416246
Report Number3008439199-2020-00022
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 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSET ROTAREX®S 6F X 135CM
Device Catalogue Number80237
Device Lot Number200475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
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: 07/24/2020 Patient Sequence Number: 1
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