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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
Model Number VERSION 1.0
Device Problems Break (1069); Overheating of Device (1437); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2023
Event Type  malfunction  
Event Description
It was reported that during a recanalization procedure for chronic total occlusion of superficial femoral artery via contralateral groin access, the catheter was allegedly became hot.It was further reported that while removing the device, the catheter was removed but the tip of the catheter didn't come out and remained in the sheath because the helix of the rotarex had allegedly fractured.Reportedly, the tip of the catheter was easily removed from the patient without any additional intervention because the broken portion of the helix had made it out of the sheath.There was no reported patient injury.
 
Manufacturer Narrative
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2024).
 
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: 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 51 cm from the tip of the catheter.Therefore, the investigation is confirmed for the reported break issue.A definitive root cause could not be determined based upon the available information.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: 07/2024), g3, h6 (device) h11: h6 (method, result, conclusion) h11: section a through f: the information provide 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 that during a recanalization procedure for chronic total occlusion of superficial femoral artery via contralateral groin access, the catheter was allegedly became hot.It was further reported that while removing the device, the catheter was removed but the tip of the catheter didn't come out and remained in the sheath because the helix of the rotarex had allegedly fractured.Reportedly, the tip of the catheter was easily removed from the patient without any additional intervention because the broken portion of the helix had made it out of the sheath.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 Key16580015
MDR Text Key311930786
Report Number3008439199-2023-00033
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810582
UDI-Public(01)07640142810582
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVERSION 1.0
Device Catalogue Number80237
Device Lot Number220159
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2023
Initial Date FDA Received03/21/2023
Supplement Dates Manufacturer Received05/13/2023
Supplement Dates FDA Received05/17/2023
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 SexMale
Patient RaceWhite
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