MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; CATHETER, CORONARY, ATHERECTOMY

Model Number	H749394671250
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Output Problem (3005); Noise, Audible (3273); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a device removal difficulty and sheath damage occurred.A 1.25 mm rotapro was selected for the rotablation procedure.During withdrawal in dynaglide mode, the physician encountered resistance accompanied by a high-pitched sound, a sudden rise in rotational speed.After the rotapro system was removed, a portion of the sheath appeared to have perished or burned away.There were no patient complications, and the patient is expected to make a full recovery.
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.E1: initial reporter phone: (b)(6).Investigation results: 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.Media review: media attached in the record depicted a torn sheath, confirming the reported sheath tear and aligning to what was found during device analysis.The additional reported events could not be confirmed with the media provided.Device analysis findings: returned product consisted of the burr catheter to the rotapro atherectomy device.The advancer portion of the device failed to return for further analysis.Visual inspection of the device found that the sheath was torn 25.5cm distal from the strain relief.The coil was stretched from the handshake connection to the burr end of the device, and the burr annulus was damaged.Product analysis could not confirm the reported noise, or the speed issue as clinical circumstances could not be replicated.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 performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of adverse event related to procedure.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.Product analysis confirmed the reported sheath tear, and difficulty removing the device as the sheath was torn.Additionally, the coil was stretched from the handshake connection to the burr end of the device, and the burr annulus was damaged.The damages present indicate tensile force was applied consistent with device removal difficulties.A torn sheath, depending on location of the tear, is most consistent to overtightening of a hemostatic valve as there is no evidence of a worn sheath which is consistent to rotational interaction with the coil.However, with the reported information provided, there is no evidence that a y-valve was present.
Event or Problem Description
It was reported that a device removal difficulty and sheath damage occurred.A 1.25 mm rotapro was selected for the rotablation procedure.During withdrawal in dynaglide mode, the physician encountered resistance accompanied by a high-pitched sound, a sudden rise in rotational speed.After the rotapro system was removed, a portion of the sheath appeared to have perished or burned away.There were no patient complications, and the patient is expected to make a full recovery.

• 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 ; 7634941632
• MDR Report Key: 24491420
• Report Number: 2124215-2026-11476
• Device Sequence Number: 10681911
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)271217(10)38213357
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 0038213357
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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 Sex: Unknown