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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device detachment occurred.The target lesion was located in the posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During the procedure, standard set up of the rotablator was performed and set the speed to 170k rpm.The burr was inserted to the lesion and several atherectomy runs were performed.However, when the last run was performed, during removal of the device, it was noted that the burr detached from the end of the advancer.The physician states that the burr never stalled or stuck at any point.The rotaburr and rotawire were gently pulled out together without incident.In addition, the patient had- an abnormal lfts and/or blood counts but the device or procedure did not cause or contributed to the patient's complication according to the physician's opinion.
Additional Manufacturer Narrative
F10.Device code - added entrapment of device.
Event or Problem Description
It was reported that a device detachment occurred.The target lesion was located in the posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During the procedure, standard set up of the rotablator was performed and set the speed to 170k rpm.The burr was inserted to the lesion and several atherectomy runs were performed.However, when the last run was performed, during removal of the device, it was noted that the burr detached from the end of the advancer.The physician states that the burr never stalled or stuck at any point.The rotaburr and rotawire were gently pulled out together without incident.In addition, the patient had- an abnormal lfts and/or blood counts but the device or procedure did not cause or contributed to the patient's complication according to the physician's opinion.It was further reported that the peripheral rotalink plus became stuck to the rotawire, the physician was able to gently pull the rotawire and the rotalink plus out together.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the burr was detached and that the coil had been stretched and broken at the point of detachment from the burr.
Event or Problem Description
It was reported that a device detachment occurred.The target lesion was located in the posterior tibial artery.A 1.25mm peripheral rotalink plus was selected for use.During the procedure, standard set up of the rotablator was performed and set the speed to 170k rpm.The burr was inserted to the lesion and several atherectomy runs were performed.However, when the last run was performed, during removal of the device, it was noted that the burr detached from the end of the advancer.The physician states that the burr never stalled or stuck at any point.The rotaburr and rotawire were gently pulled out together without incident.In addition, the patient had- an abnormal lfts and/or blood counts but the device or procedure did not cause or contributed to the patient's complication according to the physician's opinion.It was further reported that the peripheral rotalink plus became stuck to the rotawire, the physician was able to gently pull the rotawire and the rotalink plus out together.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16127984
• Report Number: 2124215-2022-55773
• Device Sequence Number: 15371830
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 02/03/2023

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: 06/21/2024
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0029636098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 02/02/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/19/2023; 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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
• Patient Race: White