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

Model Number	H749236310030
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Material Separation (1562); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck and detached requiring additional intervention.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for percutaneous transluminal coronary angioplasty (ptca).The burr was advanced to the in-stent restenosis with resistance and during attempted ablation, the burr became stuck and detached.Retrieval of the burr was achieved using other medical equipment and the rotawire.Another method was used to complete the procedure.The patient fully recovered and was discharged with no complications.
Event or Problem Description
It was reported that the burr became stuck and detached requiring additional intervention.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for percutaneous transluminal coronary angioplasty (ptca).The burr was advanced to the in-stent restenosis with resistance and during attempted ablation, the burr became stuck and detached.Retrieval of the burr was achieved using other medical equipment and the rotawire.Another method was used to complete the procedure.The patient fully recovered and was discharged with no complications.
Additional Manufacturer Narrative
(b)(6).Media evaluated by manufacturer: the device was not returned for analysis.However, photos were attached to the complaint record showing the rotablator device with the coil and sheath cut near the burr housing strain relief.Cutting the burr catheter near the housing is a known technique during retrieval of the burr after a detachment.It was considered unlikely that the cut coil and sheath shown in the attached photos are the detachment indicated within the reported events.As the remainder of the burr catheter was not shown within the attached photo, the burr detachment cited in the reported events could not be confirmed using the attached photo.
Event or Problem Description
It was reported that the burr became stuck and detached requiring additional intervention.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for percutaneous transluminal coronary angioplasty (ptca).The burr was advanced to the in-stent restenosis with resistance and during attempted ablation, the burr became stuck and detached.Retrieval of the burr was achieved using other medical equipment and the rotawire.Another method was used to complete the procedure.The patient fully recovered and was discharged with no complications.
Additional Manufacturer Narrative
E1: initial reporter address 1: sec 38 medanta the medicity, near ta.Correction: h6 device codes.Investigation results: device technical analysis: inspection of the device found that the advancer and burr catheter were connected at the handshake connection.The returned coil portion was stretched and detached at 10.8cm from the proximal end of the burr catheter handshake connection.For 3mm in length running distal from the strain relief, the sheath was kinked, worn, and torn.The damages present are consistent to when the device is cut during the procedure.Media inspection: photos provided depicted the rotablator plus device atop the product tray.Majority of the catheter portion of the device appeared to be detached near the strain relief with no visible signs of the detached distal portion within the media provided.Cutting the burr catheter near the housing is a known technique during retrieval of the burr after a detachment.Based on the photo quality, it is unknown if the proximal portion of the coil is present within the sheath; however, the burr catheter and advancer are shown connected at the burr housing and advancer nose.Additionally, the advancer knob was shown dismantled from the advancer body.Despite detachment visibility in the media provided, it is considered unlikely that the detachment shown in the attached photos is the detachment indicated within the reported events.As the remainder of the burr catheter was not shown within the attached photo, the reported events could not be confirmed with the media provided.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.Risk review: a risk review was completed and confirmed that the events of stuck in lesion, separation, and additional intervention [additional device required] were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labelling 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.Conclusion: based on a thorough review of the dhr and reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.Product analysis could not confirm the reported events as the clinical circumstances could not be replicated.The instructions for use include testing of the device before usage within the body and state that use of the device is to be discontinued if evidence of a failure or damage is present.As the reported events do not indicate any device damages or failures during unpackaging, preparation, or testing, it was considered likely that the reported events and confirmed damages occurred due to factors encountered during the procedure which could include lesion interaction.However, there is no reported evidence to support that the reported events occurred due to a direct lesion interaction.

• Brand Name: ROTALINK? PLUS
• 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: 23889286
• Report Number: 2124215-2025-92988
• Device Sequence Number: 18507771
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)270326(10)36373839
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 04/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0036373839
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 03/31/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/16/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male