MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3520
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	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation results: device analysis findings: device evaluated by manufacturer: the device was returned for analysis.The device returned with the burr catheter loaded on it and it cannot be removed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Also, the spring tip was observed bent and stretched.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to procedure.Based on the reported issue of guidewire burr stuck on wire.Analysis of the returned device concluded that the burr catheter returned stuck on the rotawire.This kind of failure can be attributable to the interaction between the rotapro and rotawire, as well as procedural factors such as handling or technique at the moment to manipulate both devices, causing the observed failure.To conclude, regarding the bending and stretching of the spring tip.These kinds of failures can be also attributable to procedural factors such as handling or technique at the moment to manipulate the device, since the spring tip is a sensitive part, and any pressure or force applied to it can result in damages, such as the observed during the product analysis.Therefore, adverse event related to procedure is selected as the cause code for these failures.
Event or Problem Description
It was reported that the guidewire and burr were stuck together.The 95% stenosed target lesion was located in a moderately tortuous and moderately calcified left anterior descending artery (lad).A 330cm rotawire and 1.25mm rotalink burr were used for rotational atherectomy.During the procedure, it was noted that the guide wire and burr were stuck together and the rotation speed only reached 153000 rpm despite a speed setting of 160000 rpm.The burr and wire were removed as one unit.The procedure was completed with another of same device.There were no complications reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the guidewire and burr were stuck together.The 95% stenosed target lesion was located in a moderately tortuous and moderately calcified left anterior descending artery (lad).A 330cm rotawire and 1.25mm rotalink burr were used for rotational atherectomy.During the procedure, it was noted that the guide wire and burr were stuck together and the rotation speed only reached 153000 rpm from its set speed of 160000 rpm.The burr and wire were normally removed as one unit.The procedure was completed with another of same device.There were no complications reported, and the patient was stable post procedure.

• 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 ; 7634941632
• MDR Report Key: 24279785
• Report Number: 2124215-2026-06858
• Device Sequence Number: 9927260
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)270512(10)36492295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/26/2026

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: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0036492295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 54 KG