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

Model Number	M0011401500
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).B3.Date of event: date of event was approximated to 01/01/2025 as the exact event date was not reported.
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The target lesion was located in the peripheral artery.A 1.50mm rotablator rotalink plus and rotawire were selected for use.During the procedure, it was noted that the burr stalled twice before seizing up on the wire.The burr and wire were removed as one unit, and the procedure was completed with an alternative device.The wire had sheered.There were no patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).B3.Date of event: date of event was approximated to (b)(6) 2025 as the exact event date was not reported.Device evaluated by manufacturer: the complaint device was received for analysis.A visual examination of the device found that at 66.5cm from the distal end of the sheath, the sheath was torn.When disconnecting the advancer from the burr catheter at the handshake connection to aid in wire removal, the wire was not visible despite being visible on both proximal and distal ends of the rotalink device indicating a fractured wire.Both portions of the wire were removed without issue or resistance.The sheath and saline infusion line contained blood.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline and blood within the device.It was considered likely that the presence of dried saline interfered with the device's ability to rotate during analysis leading to a device stall.A microscopic examination of the device found no further damage or irregularity.When the rotalink advancer was connected to the rotablator console control system and the foot pedal was pressed, the device stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The target lesion was located in the peripheral artery.A 1.50mm rotablator rotalink plus and rotawire were selected for use.During the procedure, it was noted that the burr stalled twice before seizing up on the wire.The burr and wire were removed as one unit, and the procedure was completed with an alternative device.The wire had sheered.There were no patient complications reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, 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: 21459875
• Report Number: 2124215-2025-09825
• Device Sequence Number: 12703680
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: (01)08714729838906(17)210320(10)23518843
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 03/20/2021
• Device Model Number: M0011401500
• Device Catalogue Number: M0011401500
• Device Lot Number: 0023518843
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2019
• 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