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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY
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STRAUB MEDICAL AG ROTAREX; THROMBECTOMY & ATHERECTOMY Back to Search Results
Catalog Number 80219
Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2025) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
 
Event Description
It was reported that during a recanalization procedure in the popliteal artery, when the tube was sent to the superficial femoral artery, it could no longer be pushed forward.It was further reported that upon withdrawal of the catheter, the tip was allegedly found to be deformed.The procedure was completed by using another device.There was no reported patient injury.
 
Event Description
It was reported that during a recanalization procedure in the popliteal artery, when the tube was sent to the superficial femoral artery, it could no longer be pushed forward.It was further reported that upon withdrawal of the catheter, the tip was allegedly found to be deformed.The procedure was completed by using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the catheter was returned for evaluation and hence, a physical investigation was performed for the catheter.During physical investigation, the tube and helix inside of the rotarex was kinked at one centimeter from the tip of the catheter.The test guidewire did not pass through the catheter.It was not possible to achieve any rotations.The catheter was opened, and a lot of bodily material found inside around the helix.Therefore, the investigation is confirmed for the reported kink of the rotarex catheter.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 12/2025), g3, h6 (device).H11: d3, e1, g1, h6 (method, result, conclusion).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
 
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Brand Name
ROTAREX
Type of Device
THROMBECTOMY & ATHERECTOMY
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
ch-7323
wangs SG 73 23
SZ  SG 7323
Manufacturer (Section G)
STRAUB MEDICAL AG
straubstrasse 12
ch-7323
wangs SG 73 23
SZ   SG 7323
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18738827
MDR Text Key336894651
Report Number3008439199-2024-00019
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K211738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80219
Device Lot Number220337
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
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 Sequence Number1
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