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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The target lesion was located in the severely calcified proximal segment of the left anterior descending artery.A 1.50mm rotalink burr and a rotawire were selected for use.During the procedure, it was noted that the burr was stuck with the rotawire.Furthermore, the guidewire could not cross.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The target lesion was located in the severely calcified proximal segment of the left anterior descending artery.A 1.50mm rotalink burr and a rotawire were selected for use.During the procedure, it was noted that the burr was stuck with the rotawire.Furthermore, the guidewire could not cross.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable after the procedure.It was further reported that severely stenosed target lesion was located in the severely tortuous and severely calcified proximal segment of the left anterior descending artery.The rotawire has reached the lesion, but while the burr was being advanced, it was found that the burr could not cross the rotawire, so the burr did not reach the inside of the patient.Additionally, the physician directly replaced the burr, not using other devices to remove it.
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The target lesion was located in the severely calcified proximal segment of the left anterior descending artery.A 1.50 mm rotalink burr and a rotawire were selected for use.During the procedure, it was noted that the burr was stuck with the rotawire.Furthermore, the guidewire could not cross.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable after the procedure.It was further reported that severely stenosed target lesion was located in the severely tortuous and severely calcified proximal segment of the left anterior descending artery.The rotawire has reached the lesion, but while the burr was being advanced, it was found that the burr could not cross the rotawire, so the burr did not reach the inside of the patient.Additionally, the physician directly replaced the burr, not using other devices to remove it.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the coil was kinked at the handshake connection.A microscopic inspection of the device found that the coil stretched from the handshake connection to 2 cm proximal from the burr.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be inserted into the burr catheter both distally and proximally but was unable to be advanced due to the kinked coil.No other issues were identified during the product analysis.

• Brand Name: ROTALINK BURR
• 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: 21367861
• Report Number: 2124215-2025-07450
• Device Sequence Number: 8519227
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: (01)08714729185857(17)260903(10)34763607
• 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): 03/31/2025

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 Expiration Date: 09/03/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0034763607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/16/2025; 03/10/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/10/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 72 KG