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); Device-Device Incompatibility (2919); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Lot number: detailed product information was not provided to bsc.Good faith effort attempt was made to try and retrieve the product details.
Event or Problem Description
It was reported that the devices were difficult to remove, requiring additional intervention.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 1.50mm rotapro and rotawire were selected for use.During the procedure in the right coronary artery, difficulty in passing the balloons and getting them to expand well was encountered.A non-boston scientific (non-bsc) stent was placed in the proximal portion of the right coronary artery.Following placement, rota was attempted in the middle portion.During the procedure, when the rota portion of the procedure was completed, an attempt was made to remove the burr, however the rotapro burr became stuck on the edge of the stent.A second wire was used to attempt and balloon to the edge of the stent to allow the burr to exit, however, the wire could not pass through the stent.It appeared that the other wire was frayed on to the burr when an attempt was made to pass a wire up to balloon to the edge of the stent.The rotapro burr was cut off of the advancer.A guide extension was then used to mitigate and that also would not pass.The guide was then removed, the frayed piece was pulled off of the wire, and the rotawire and rotapro were removed together.There was no patient complications noted post procedure.

• 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 01752
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21381708
• Report Number: 2124215-2025-06116
• Device Sequence Number: 20929587
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 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): 02/13/2025

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: 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: 01/16/2025
• Initial Report FDA Received Date: 02/13/2025
• 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.; SECOND WIRE.; STENT: ONYX.
• Patient Sex: Unknown