MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number	VERSION 1.0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure through common femoral artery, the device was inserted over the wire through the sheath.It was further reported that the device was activated and engaged with the clot and clutched out.Furthermore, the device was removed to be flushed and, upon removal of the catheter, the distal tip and helix of the catheter remained in the sheath.Under fluoroscopy, it was allegedly found that the helix was fractured and separated from the catheter.Reportedly, the device was removed with a snare and the procedure was completed using another device.There was no reported patient injury.
Additional 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: 08/2024).Device pending return.
Additional 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 and a physical investigation was performed for the catheter.The helix was broken at 21 cm distance from the tip of the catheter, with a tube kink found at the same place of 21 cm.Therefore, the investigation is confirmed for the reported helix 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: 08/2024).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.
Event or Problem Description
It was reported that during a recanalization procedure through common femoral artery, the device was inserted over the wire through the sheath.It was further reported that the device was activated and engaged with the clot and clutched out.Furthermore, the device was removed to be flushed and, upon removal of the catheter, the distal tip and helix of the catheter remained in the sheath.Under fluoroscopy, it was allegedly found that the helix was fractured and separated from the catheter.Reportedly, the device was removed with a snare and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: ROTAREX
• Common Device Name: 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 Key: 16748370
• Report Number: 3008439199-2023-00054
• Device Sequence Number: 3379410
• Product Code: MCW
• UDI-Device Identifier: 07640142810605
• UDI-Public: (01)07640142810605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: VERSION 1.0
• Device Catalogue Number: 80239
• Device Lot Number: 220773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 04/15/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown