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

Model Number	H749236310040
Medical Device Problem Codes	Entrapment of Device (1212); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.E1 initial reporter phone:(b)(6).
Event or Problem Description
It was reported that a burr and guidewire entanglement occurred.The target lesion was located in the anterior descending branch.A 1.75mm rotablator rotalink plus and a 330cm rotawire were selected for use.During preparation, the rotational speed was tested normally; however, the rotawire could not rotate with the burr, but the burr rotated normally, and the advancer moved normally.Upon entering the patient's body, the burr was able to move forward normally in the guiding catheter and was nearly delivered out of the guiding catheter port.However, it was noted that the devices were entangled and the test was conducted in vitro.The rotawire and burr were removed together.The procedure was completed with another of the same device.No patient complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.E1 initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The burr catheter was received attached to the advancer.Visual inspection of the device identified that the coil was stretched for a length of 5.4cm running proximal from the burr catheter.The wire reported in the procedure failed to return with the complaint device so a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted into the burr; however, when advanced through the burr catheter, the wire failed to pass due to the coil damage present.The rotablator system was able to be connected to the rotablator control console system, and when tested, the device stalled and would not run.To confirm the damage present is the cause of the stall, the burr catheter was removed from the advancer for further testing.The advancer was able to reach and maintain optimal speed without issue or resistance.
Event or Problem Description
It was reported that a burr and guidewire entanglement occurred.The target lesion was located in the anterior descending branch.A 1.75mm rotablator rotalink plus and a 330cm rotawire were selected for use.During preparation, the rotational speed was tested normally; however, the rotawire could not rotate with the burr, but the burr rotated normally, and the advancer moved normally.Upon entering the patient's body, the burr was able to move forward normally in the guiding catheter and was nearly delivered out of the guiding catheter port.However, it was noted that the devices were entangled and the test was conducted in vitro.The rotawire and burr were removed together.The procedure was completed with another of the same device.No patient complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter zip/post code - updated.A2 age at time of event: 18 years or older.(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The burr catheter was received attached to the advancer.Visual inspection of the device identified that the coil was stretched for a length of 5.4cm running proximal from the burr catheter.The wire reported in the procedure failed to return with the complaint device so a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted into the burr; however, when advanced through the burr catheter, the wire failed to pass due to the coil damage present.The rotablator system was able to be connected to the rotablator control console system, and when tested, the device stalled and would not run.To confirm the damage present is the cause of the stall, the burr catheter was removed from the advancer for further testing.The advancer was able to reach and maintain optimal speed without issue or resistance.
Event or Problem Description
It was reported that a burr and guidewire entanglement occurred.The target lesion was located in the anterior descending branch.A 1.75mm rotablator rotalink plus and a 330cm rotawire were selected for use.During preparation, the rotational speed was tested normally; however, the rotawire could not rotate with the burr, but the burr rotated normally, and the advancer moved normally.Upon entering the patient's body, the burr was able to move forward normally in the guiding catheter and was nearly delivered out of the guiding catheter port.However, it was noted that the devices were entangled and the test was conducted in vitro.The rotawire and burr were removed together.The procedure was completed with another of the same device.No patient complications were reported, and patient was stable post procedure.

• 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: 22331166
• Report Number: 2124215-2025-40660
• Device Sequence Number: 8300603
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)270121(10)35897873
• 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,Followup
• Report Date (Section B): 12/11/2025

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: H749236310040
• Device Catalogue Number: H749236310040
• Device Lot Number: 0035897873
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 11/13/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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