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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Noise, Audible (3273); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr stuck with the wire.The 50% stenosed target lesion was located in the moderately tortuous and 70% calcified tibial area.A 1.25mm peripheral rotalink plus and rotawire were selected for use.During the procedure, the device made an abnormal sound and it stopped.The burr was stuck and could not come out as a whole system with wire.The devices were pulled out using a non-bsc support catheter.It was reported the wire may have detached and the burr was stuck.The devices were removed completely from the patient and the procedure was completed using angioplasty.No complications were reported, and patient was fine post procedure.
Event or Problem Description
It was reported that the burr stuck with the wire.The 50% stenosed target lesion was located in the moderately tortuous and 70% calcified tibial area.A 1.25mm peripheral rotalink plus and rotawire were selected for use.During the procedure, the device made an abnormal sound and it stopped.The burr was stuck and could not come out as a whole system with wire.The devices were pulled out using a non-bsc support catheter.It was reported the wire may have detached and the burr was stuck.The devices were removed completely from the patient and the procedure was completed using angioplasty.No complications were reported, and patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the peripheral rotalink device was connected to the rotablator console control system and the foot pedal was pressed while the returned rotawire was inserted, the device staled and would not run.Abnormal noises were heard coming from the device during attempted rotation.Further functional testing was performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted due to a kink in the proximal end of the wire.In order to determine the functionality of the peripheral rotalink device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the rotablator device with no resistance or issues.The peripheral rotalink device was then reconnected to the rotablator console control system.When the foot pedal was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.Product analysis confirmed the reported events, as the device stalled and generated abnormal noises during attempted rotation with the returned rotawire inserted but, was able to reach and maintain optimal rpm after the returned wire was removed with resistance.The returned wire was unable to be reinserted into the device due to a kink in the wire.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17405899
• Report Number: 2124215-2023-37270
• Device Sequence Number: 15234217
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• 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): 08/29/2023

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: 03/05/2025
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0031175595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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 Sex: Unknown