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

Model Number	H749394672000
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire got separated.A 1.50mm rotapro, 2.00mm rotapro and two ng rotawire floppy 5 pack were selected for use.During removal using dynaglide, the advancer and the wire became stuck midway and then were removed together.An additional ablation was performed with a second burr and rotawire.When attempting to remove the wire, the rotawire came out, likely causing a rupture of the opaque portion of the rotawire due to contact with the burr.It had to come out to the proximal area, so it could be easily removed using a snare.The procedure was completed with another of the same device.There was no patient injury and the patient was stable.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.B1: adverse event/product problem: corrected.B:2: outcomes attrib to adv event: corrected.H1: type of reportable event: corrected.H6: impact codes: corrected.
Event or Problem Description
It was reported that the wire got separated.A 1.50mm rotapro, 2.00mm rotapro and two ng rotawire floppy 5 pack were selected for use.During removal using dynaglide, the advancer and the wire became stuck midway and then were removed together.An additional ablation was performed with a second burr and rotawire.When attempting to remove the wire, the rotawire came out, likely causing a rupture of the opaque portion of the rotawire due to contact with the burr.It had to come out to the proximal area, so it could be easily removed using a snare.The procedure was completed with another of the same device.There was no patient injury and the patient was stable.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23137461
• Report Number: 2124215-2025-65946
• Device Sequence Number: 13082583
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)270318(10)36088916
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0036088916
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/13/2025
• Date Device Manufactured: 03/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown