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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 80239
Device Problems Retraction Problem (1536); Stretched (1601); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2023
Event Type  malfunction  
Event Description
It was reported that during a recanalization procedure in the right femoral artery via the left femoral access, when the physician retracted the device out of the sheath, the tip of the device and the inner helix allegedly stretched apart more than the normal.It was further reported that the device was allegedly difficult to be retrieved through the sheath.The procedure was completed using another device.There was no reported patient 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: 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.H10: d4: (expiration date: 11/2025).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.
 
Event Description
It was reported that during a recanalization procedure in the right femoral artery via the left femoral access, when the physician retracted the device out of the sheath, the tip of the device and the inner helix allegedly stretched apart more than the normal.It was further reported that the device was allegedly difficult to be retrieved through the sheath.The procedure was completed using another device.There was no reported patient 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: 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.The catheter was physically investigated.During physical investigation, the tip of the catheter was stuck with bodily material and test guidewire passed until the tip of the catheter.After running in the water slightly lower than nominal aspiration level was achieved.Mechanical jam was observed during the investigation.Therefore, the investigation cannot be confirmed for the reported stretch and retraction problem.A clear root cause could not be identified but a blockage of the catheter 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 (expiration date: 11/2025).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.
 
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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 Key18587048
MDR Text Key334834527
Report Number3008439199-2024-00004
Device Sequence Number1
Product Code MCW
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 02/23/2024
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 Catalogue Number80239
Device Lot Number230896
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2024
Initial Date FDA Received01/26/2024
Supplement Dates Manufacturer Received02/19/2024
Supplement Dates FDA Received02/26/2024
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
Patient Age75 YR
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