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

Model Number	M0011402000
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was dislodged and stuck in the lesion.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 2.00mm peripheral rotalink plus and peripheral rotawire guidewire were selected for tibial artery atherectomy.During the procedure, it was noted that the wire and the device were lodged in a chronic occlusion in the peroneal artery.The devices could not be withdrawn through the common femoral arteriotomy.Intervention included exposing the peroneal artery through the lower leg to cut the device free at the distal end of the device.The rest of the rotablator was removed from the sheath.The procedure was completed.The patient did not experience any complications, and the patient was expected to fully recover.
Event or Problem Description
It was reported that the burr was dislodged and stuck in the lesion.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 2.00mm peripheral rotalink plus and peripheral rotawire guidewire were selected for tibial artery atherectomy.During the procedure, it was noted that the wire and the device were lodged in a chronic occlusion in the peroneal artery.The devices could not be withdrawn through the common femoral arteriotomy.Intervention included exposing the peroneal artery through the lower leg to cut the device free at the distal end of the device.The rest of the rotablator was removed from the sheath.The procedure was completed.The patient did not experience any complications, and the patient was expected to fully recover.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was not returned for analysis.Photos were provided showing patient anatomy both under imaging and to the naked eye.The reported stuck burr could not be confirmed using the attached photos as there is no evidence of resistance within the attached photo of imaging.The reported surgical intervention could be confirmed, as there is evidence of intervention beyond use of the device.
Event or Problem Description
It was reported that the burr was dislodged and stuck in the lesion.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 2.00mm peripheral rotalink plus and peripheral rotawire guidewire were selected for tibial artery atherectomy.During the procedure, it was noted that the wire and the device were lodged in a chronic occlusion in the peroneal artery.The devices could not be withdrawn through the common femoral arteriotomy.Intervention included exposing the peroneal artery through the lower leg to cut the device free at the distal end of the device.The rest of the rotablator was removed from the sheath.The procedure was completed.The patient did not experience any complications, and the patient was expected to fully recover.It was further reported that the lesion was 4-5mm long.The patient was medicated with verapimil and nitro in the rotaglide solution.The procedure was aborted.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was not returned for analysis.Photos were provided showing patient anatomy both under imaging and to the naked eye.The reported stuck burr could not be confirmed using the attached photos as there is no evidence of resistance within the attached photo of imaging.The reported surgical intervention could be confirmed, as there is evidence of intervention beyond use of the device.
Event or Problem Description
It was reported that the burr was dislodged and stuck in the lesion.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peripheral artery.A 2.00mm peripheral rotalink plus and peripheral rotawire guidewire were selected for tibial artery atherectomy.During the procedure, it was noted that the wire and the device were lodged in a chronic occlusion in the peroneal artery.The devices could not be withdrawn through the common femoral arteriotomy.Intervention included exposing the peroneal artery through the lower leg to cut the device free at the distal end of the device.The rest of the rotablator was removed from the sheath.The procedure was completed.The patient did not experience any complications, and the patient was expected to fully recover.It was further reported that the lesion was 4-5mm long.The patient was medicated with verapimil and nitro in the rotaglide solution.The procedure was aborted.

• 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: 23310492
• Report Number: 2124215-2025-71899
• Device Sequence Number: 4967584
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: (01)08714729838920(17)251207(10)33015194
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 04/29/2026

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 Expiration Date: 12/07/2025
• Device Model Number: M0011402000
• Device Catalogue Number: M0011402000
• Device Lot Number: 0033015194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 12/01/2025; 02/26/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/18/2025; 12/26/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 125 KG