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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 80224
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/24/2023
Event Type  malfunction  
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2025).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.H3 other text : device pending return.
 
Event Description
It was reported that during a recanalization procedure in the lower extremity arteries, the catheter was allegedly broken in the middle of the sheath.It was further reported that the internal spring of the catheter allegedly broke and had cut the sheath.Reportedly, the catheter was removed along with the outer sheath, and 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: 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 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 and hence physical investigation was performed for the catheter.During physical investigation the helix was broken at 57 cm distance from the tip of the catheter.The tube was damaged at the same position 57 cm from the tip of the catheter.It was not possible to specify the root cause further using the information provided by the user.Therefore, the investigation is confirmed for the reported helix break.The definitive root cause could not be determined based upon available information.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: 01/2025).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 lower extremity arteries, the catheter was allegedly broken in the middle of the sheath.It was further reported that the internal spring of the catheter allegedly broke and had cut the sheath.Reportedly, the catheter was removed along with the outer sheath, and the procedure was completed 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 Key18524540
MDR Text Key332980290
Report Number3008439199-2023-00242
Device Sequence Number1
Product Code KNW
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 02/20/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/17/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number80224
Device Lot Number230353
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2024
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 Age66 YR
Patient SexMale
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