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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); Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 10/09/2023
Event Type  Injury  
Manufacturer Narrative
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: 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: 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.H10: d4 (expiry date: 06/2026).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.
 
Event Description
It was reported through the results of a clinical trial that during a recanalization procedure in the occluded left superficial femoral artery, the patient allegedly experienced pain in the left mid superficial femoral artery.It was further reported that the catheter was removed.Furthermore, it was found that the tip of the guidewire had allegedly torn off in a small side branch of the popliteal artery at the tibial plateau upon removal.Moreover, tried in vain to remove the broken guidewire tip with a snare device and after one and half hours, it was decided that without hemodynamic effects the tip could remain and then the patient was discharged.However, the patient allegedly came back with pain in the back of the left knee.Reportedly, the patient underwent additional medical intervention and it was finally possible to remove the broken guidewire tip (around twelve-centimeter) with a snare device.Apparently, there were no further dissections or paravasat visible and the patient was discharged.The current status of the patient is unknown.
 
Event Description
It was reported through the results of a clinical trial that during a recanalization procedure in the occluded left superficial femoral artery, the patient allegedly experienced pain in the left mid superficial femoral artery.It was further reported that the catheter was removed.Furthermore, it was found that the tip of the guidewire had allegedly torn off in a small side branch of the popliteal artery at the tibial plateau upon removal.Moreover, tried in vain to remove the broken guidewire tip with a snare device and after one and half hours, it was decided that without hemodynamic effects the tip could remain and then the patient was discharged.However, the patient allegedly came back with pain in the back of the left knee.Reportedly, the patient underwent additional medical intervention and it was finally possible to remove the broken guidewire tip (around twelve-centimeter) with a snare device.Apparently, there were no further dissections or paravasat visible and the patient was discharged.The current status of the patient is unknown.
 
Manufacturer Narrative
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: 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 for the catheter was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation and hence physical investigation was not possible.User provided information regarding guidewire break.Therefore, the investigation can not be confirmed for the reported malfunction.A clear root cause could not be identified but a damaged guidewire represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 06/2026), g3, h6 (method).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 not returned.
 
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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 Key18308555
MDR Text Key330223708
Report Number3008439199-2023-00212
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K211738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80202
Device Lot Number231077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexFemale
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