MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX & ASPIREX DRIVE SYSTEM; THROMBECTOMY & ATHERECTOMY

Catalog Number	80300
Medical Device Problem Codes	Break (1069); Self-Activation or Keying (1557); Power Problem (3010); Intermittent Loss of Power (4016); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the serial 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: 09/2025).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 or Problem Description
It was reported that prior to a thrombectomy and atherectomy procedure, the device has no known issue.It was further reported that however, after evaluation at the service center, it was found that the device foot switch was allegedly activated on it's own, the foot switch was allegedly difficult to unplug, and the motor wire was allegedly loosened.There was no patient contact.
Additional Manufacturer Narrative
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 driver, control unit, motor and foot switch were returned for evaluation and were physically investigated.During physical inspection a damage of the case and the foot switch discovered.Furthermore, the cable of the motor was damaged.The reported incomplete or inadequate connection can be confirmed due to the damaged power cable of the motor.The reported intermittent loss of power can be confirmed due to the break of the motor.The reported self-activation or keying can not be confirmed, as the malfunction was not re-producible during investigation.A clear root cause could not be established.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: 09/2025), g3, h6 (device).H11: h6 (method, result, conclusion).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 or Problem Description
It was reported that prior to a thrombectomy and atherectomy procedure, the device has no known issue.It was further reported that however, after evaluation at the service center, it was found that the device foot switch was allegedly activated on its own, the foot switch was allegedly difficult to unplug, and the motor wire was allegedly loosened.There was no patient contact.

• Brand Name: ROTAREX & ASPIREX DRIVE SYSTEM
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; ch-7323; wangs SG 73 23; SZ SG 7323
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19672694
• Report Number: 3008439199-2024-00115
• Device Sequence Number: 6587477
• Product Code: MCW
• UDI-Device Identifier: 07640142810889
• UDI-Public: (01)07640142810889
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 80300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown