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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY
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UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY Back to Search Results
Catalog Number 80202
Device Problems Break (1069); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Event Description
It was reported that during a recanalization procedure in left femoral artery via retrograde puncture, the catheter tip was allegedly did not rotate.It was further reported that the spring attached to the catheter tip was allegedly ruptured.The procedure was completed by using another device.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified 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.The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2024).
 
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: 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 sample was returned for evaluation.A physical investigation was performed for the catheter.The helix was broken at 62 cm from the tip of the catheter.It can be confirmed that the helix was broken.A clear root cause could not be established.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 05/2024), g3, h6(conclusion) h11: g1, h6(method, result) h11:section a through f - the information provided by bd represents all of 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.
 
Event Description
It was reported that during a recanalization procedure in left femoral artery via retrograde puncture, the catheter tip was allegedly did not rotate.It was further reported that the spring attached to the catheter tip was allegedly ruptured.The procedure was completed by using another device.There was no reported patient injury.
 
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Brand Name
ROTAREX
Type of Device
THROMBECTOMY & ATHERECTOMY
Manufacturer (Section D)
UNKNOWN
BR 
Manufacturer (Section G)
UNKNOWN
BR  
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13886315
MDR Text Key290459092
Report Number3008439199-2022-00021
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 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80202
Device Lot Number211390
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
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
Patient Age67 YR
Patient SexMale
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