MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	H749394672000
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Integrity Problem (2978)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A 1.75mm rotapro, 2.00mm rotapro and a rotapro console were selected for use.During the preparation, the 2.00mm burr would not turn on.The gas and connection were checked.Then used a 1.75mm burr, but the issue persisted.The physician commented that the patient acquired a thrombosis while troubleshooting the device.They had to do thrombectomy with penumbra.The procedure was completed with another burr.Upon investigation it appeared that the console electrical piece no longer aligned to allow connection between burr and the console.No further patient complications were reported and expected patient to fully recover.
Additional Manufacturer Narrative
B5 describe event or problem: corrected.H6 device codes: corrected.
Event or Problem Description
It was reported that thrombosis occurred.A 1.75mm rotapro, 2.00mm rotapro and a rotapro console were selected for use.During the preparation, the 2.00mm burr would not turn on.The gas and connection were checked.Then used a 1.75mm burr, but the issue persisted.The physician commented that the patient acquired a thrombosis while troubleshooting the device.They had to do thrombectomy with penumbra.The procedure was completed with another burr.Upon investigation it appeared that the console electrical piece no longer aligned to allow connection between burr and the console.No further patient complications were reported and expected patient to fully recover.It was further reported that the procedure was completed with an alternative method.
Additional Manufacturer Narrative
B5 describe event or problem: corrected.H6 device codes: corrected.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found no damage or irregularity.After destructive testing was performed, it was found that the shutter was damaged.Shutter damage could lead to fiberoptic interference.During analysis, the dynaglide mode change button, the dynaglide momentary on button, and the ablation button were tested and found to respond when pressed with no resistance or issues.The rotapro advancer was connected to the rotapro control console system.The device stalled and would not run.In order to determine the reason for the device stall, the advancer was dismantled and the components inside the advancer were inspected.Product analysis did not confirm the reported event, as the dynaglide mode change button, the dynaglide momentary on button, and the ablation button were tested and found to respond when pressed with no resistance or issues.
Event or Problem Description
It was reported that thrombosis occurred.A 1.75mm rotapro, 2.00mm rotapro and a rotapro console were selected for use.During the preparation, the 2.00mm burr would not turn on.The gas and connection were checked.Then used a 1.75mm burr, but the issue persisted.The physician commented that the patient acquired a thrombosis while troubleshooting the device.They had to do thrombectomy with penumbra.The procedure was completed with another burr.Upon investigation it appeared that the console electrical piece no longer aligned to allow connection between burr and the console.No further patient complications were reported and expected patient to fully recover.It was further reported that the procedure was completed with an alternative method.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20695699
• Report Number: 2124215-2024-69632
• Device Sequence Number: 6489311
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: 08714729999591
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2024
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0030543539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 12/12/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/12/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown