MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE Drive; catheter, coronary, atherectomy

Model Number	2077-01
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that burr stuck on wire occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified artery.A 1.50mm rotapro and rotawire drive was selected for use.During procedure, upon first ablation, the speed dropped by 3000 rpm.After starting the second ablation, an unusual noise occurred and the speed dropped by 20,000 rpm.Thus, the ablation was discontinued.The unusual noise persisted when attempting to remove the device with dynaglide.Then, the device got stuck with the wire.The rotaburr was removed from the body along with the entire rotawire.The physician stated that the clamp for the cocktail supply may not have been completely released.The procedure was completed with another of the same device.There were no patient complications.

• Brand Name: ROTAWIRE Drive
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25756495
• Report Number: 2124215-2026-36724
• Device Sequence Number: 10449782
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262(17)280127(10)38433440
• 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): 08/04/2026

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: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0038433440
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2026
• 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: GUIDE CATHETER - 7F SL 4.0.; IMAGING CATHETER - OCT.
• Patient Sex: Unknown