MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; catheter, coronary, atherectomy

Model Number	H749394672250
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Material Separation (1562); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rotalink was disconnected.The 90% stenosed target lesion was located in the tortuous and calcified mid to distal right coronary artery.A 2.25mm rotapro was selected for use.During the procedure, it was noted that a rotalink separated between the burr and the drive shaft.During removal, resistance was encountered.The fragments were successfully retrieved using a gooseneck snare, and no fragments remained inside the patient's body following the procedure.Per the physician this event occurred due to possible device deterioration resulting from repeated ablation attempts in a severely tortuous vessel, with repeated stall indications being displayed.The procedure was completed with a different device.There were no patient complications, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that the burr detached.The 90% stenosed target lesion was located in the tortuous and calcified mid to distal right coronary artery.A 2.25mm rotapro was selected for use.During the procedure, it was noted that a rotalink separated between the burr and the drive shaft.During removal, resistance was encountered.The fragments were successfully retrieved using a gooseneck snare, and no fragments remained inside the patient's body following the procedure.Per the physician this event occurred due to possible device deterioration resulting from repeated ablation attempts in a severely tortuous vessel, with repeated stall indications being displayed.The procedure was completed with a different device.There were no patient complications, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).With all the available information, boston scientific concludes: device analysis findings: the device was returned for analysis.Product analysis confirmed the reported events as the coil and burr returned detached.The burr was found to be moveable on the returned rotawire.Additionally, majority of the coil from handshake connection to the distal end of the coil was stretched indicating tensile force was applied.The returned wire was found frozen due to coil damage present.The damages present directly impacts rotational output of the device.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Medical review: based upon medical review assessment, the data reasonably suggest that the clinical event is anticipated in nature and severity as per the ifu and does not require escalation to senior management.Investigation conclusion: as a review of the device history record shows that the device was manufactured per specification, review of the instructions for use indicates that the device is not to be used if damages or defects are identified prior to use, and the reported events do not indicate any damages or defects to the device during unpackaging, it was considered likely that the reported events and the condition of the returned device occurred due to procedural factors which can include device interaction.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.
Additional Manufacturer Narrative
E1 - initial reporter address (b)(6).

• 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 ; +1(612)875-7234
• MDR Report Key: 50104976
• Report Number: 2124215-2026-41324
• Device Sequence Number: 10032477
• Product Code: MCX
• UDI-Device Identifier: 08714729999614
• UDI-Public: (01)08714729999614(17)270811(10)37181364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/15/2026

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: H749394672250
• Device Catalogue Number: H749394672250
• Device Lot Number: 0037181364
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 8F Hyperion guide catheter; 8F Hyperion guide catheter
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown