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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device entrapment occurred, requiring an additional device to remove.The target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.50mm rotapro was selected for use.During the procedure, the rotapro burr became stuck in the lesion.An attempt was made to pull to remove the rotapro burr; however, it was not successful.A second physician also attempted to remove, without success.The rotapro advancer body and driveshaft were cut to remove the outer sheath to expose the driveshaft.The procedure was completed, and the device was successfully removed by advancing a non-boston scientific guide catheter extension over the burr.The wire and rotapro burr were removed together, however they were not entangled.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding product details but was unable to be obtained.

• 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; 300 boston scientific way; marlborough MA
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21976370
• Report Number: 2124215-2025-29098
• Device Sequence Number: 7265594
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: (01)08714729893363
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/07/2025

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 Model Number: 3243
• Device Catalogue Number: 3243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETER: NON-BOSTON SCIENTIFIC.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown