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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that burr got stuck on lesion and was not retrieved.The target lesion was located in the tortuous right coronary artery (rca) with diffuse disease.A 1.5 mm rotapro was selected for use.During the procedure, the physician made four passes in the middle right coronary artery and on the fifth pass, the burr got dislodged in the lesion.The physician tried using a buddy wire to dislodge and pull but the burr did not move.The physician cut the burr from the advancer and rail the guidezilla over the burr.But it was still not moving.They tried pulling harder and the burr broke at the driveshaft.They were able to wire past the burr and continued to treat the vessel with ballooning.They used an ivus catheter down and used shockwave.After doing so, a hazy or dissected area was noted, which prompted them to stent the rca over the dislodge burr.No complications were reported, and patient was stable throughout the procedure.
Event or Problem Description
It was reported that burr got stuck on lesion and was not retrieved.The target lesion was located in the tortuous right coronary artery (rca) with diffuse disease.A 1.5 mm rotapro was selected for use.During the procedure, the physician made four passes in the middle right coronary artery and on the fifth pass, the burr got dislodged in the lesion.The physician tried using a buddy wire to dislodge and pull but the burr did not move.The physician cut the burr from the advancer and rail the guidezilla over the burr.But it was still not moving.They tried pulling harder and the burr broke at the driveshaft.They were able to wire past the burr and continued to treat the vessel with ballooning.They used an ivus catheter down and used shockwave.After doing so, a hazy or dissected area was noted, which prompted them to stent the rca over the dislodge burr.No complications were reported, and patient was stable throughout the procedure.It was further reported that the 85% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.The device was advance in a 16,000rpm set speed and reaches through a normal rpm in an appropriate technique.However, the burr got stuck while advancing and a shockwave was used that causes the dissection.

• 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; two scimed place; maple grove MN
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21875283
• Report Number: 2124215-2025-24786
• Device Sequence Number: 20799575
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: (01)08714729893363
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 05/12/2025

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: 04/01/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/12/2025
• 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: CATHETER GUIDE EXTENSION - GUIDEZILLA; CATHETER GUIDE EXTENSION - GUIDEZILLA; IVUS CATHETER; IVUS CATHETER
• Patient Sex: Unknown