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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 80277
Device Problems Material Deformation (2976); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.(expiration date: 06/2024).
 
Event Description
It was reported that during a recanalization procedure, the resistance was allegedly felt on the catheter.It was further reported that catheter head was allegedly damaged.There was no reported patient injury.
 
Event Description
It was reported that during a recanalization procedure, the resistance was allegedly felt on the catheter.It was further reported that catheter head was allegedly damaged.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 that are cleared in the us.The pro code and 510 k number for the rotarex 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 catheter was physically investigated.The catheter was blocked with thrombotic material from patients body and it was not possible to pass the guidewire through.The helix was observed out of the tube presumably due to getting stuck in the introducing sheath.The reported issue of catheter clogging and interrupted aspiration can be confirmed.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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: 06/2024).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.
 
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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 Key13912492
MDR Text Key290458920
Report Number3008439199-2022-00024
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUK
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 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80277
Device Lot Number211758
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2022
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
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