MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RotaWire and wireClip Torquer; catheter, coronary, atherectomy

Model Number	3520
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/05/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient expired.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 1.25mm rotablator plus and 330cm rotawire were selected for use.During the procedure, while doing rotational atherectomy angioplasty, the burr stuck and induced a perforation, which caused the patient to expire.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
Investigation results: device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.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.Risk review: a risk review was completed and confirmed that the event of "[perforation, death]" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation has been assigned an investigation conclusion code of known inherent risk of device.This conclusion is supported by the following objective evidence: perforation and death defined in the ifu as adverse events that can occur during procedure with the use of the device.According to the manufacturing memo, it can be confirmed that the device from batch 36549012, manufactured on may 21, 2025, was manufactured without any issue reported.The clinical event is anticipated in nature and severity.
Event or Problem Description
It was reported that the patient expired.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 1.25mm rotablator plus and 330cm rotawire were selected for use.During the procedure, while doing rotational atherectomy angioplasty, the burr stuck and induced a perforation, which caused the patient to expire.

• Brand Name: RotaWire and wireClip Torquer
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24484772
• Report Number: 2124215-2026-11394
• Device Sequence Number: 10676094
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)270522(10)36589538
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0036589538
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 08/27/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/27/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATHERECTOMY - ROTABLATOR PLUS 1.25MM; ATHERECTOMY - ROTABLATOR PLUS 1.25MM
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Male