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

Model Number	H749394671750
Medical Device Problem Codes	Device Damaged by Another Device (2915); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire separation occurred with a retained fragment and procedure was cancelled.The 30 mm long and 90% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery with a vessel diameter of 3.00- 3.40 mm.A rotawire and 1.75mm rotapro was selected for use.During removal, resistance was encountered and an unusual sound was heard.The guidewire detached 5 cm from the tip due to contact with the burr.Per the physician.The wire may have been kinked.Attempts to retrieve the device fragment with a non-boston scientific balloons, guide extension catheter and guidewire were unsuccessful.The detached device segment remained inside the patient and the procedure was cancelled as there were no additional devices available.

• 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(763)494-1632
• MDR Report Key: 25519720
• Report Number: 2124215-2026-29935
• Device Sequence Number: 18683297
• Product Code: MCX
• UDI-Device Identifier: 08714729999584
• UDI-Public: (01)08714729999584(17)280115(10)38357644
• 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): 07/30/2026

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: H749394671750
• Device Catalogue Number: H749394671750
• Device Lot Number: 0038357644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 01/15/2026
• 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: BALLOON - 1.5 RYUREI.; BALLOON - 2.0 RYUREI.; GUIDE EXTENSION -GUIDEPLUS.; GUIDEWIRE - SION BLUE.
• Patient Age: 80 YR
• Patient Sex: Male