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

Model Number	29720
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was detached and removed with a snare.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A 2.00mm peripheral rotalink plus was selected to treat the entire length of the vessel.The burr made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off completely and remained behind on the guidewire.Snares were used to remove the device successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the burr was detached and removed with a snare.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified anterior tibial vessel.A 2.00mm peripheral rotalink plus was selected to treat the entire length of the vessel.The burr made a stall sound when approximately 2-3 inches of the vessel was left to treat.Then, the rotapro catheter was removed but it was noted that the burr was sheared off and remained behind on the guidewire.Snares were used to remove the device successfully after about 3 hours of extra work.After the detached burr was removed, the vessel was rewired and ballooned to finish the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device was received with the burr separated.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil and burr were detached.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotablator 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 and the interior components were inspected for damages or defects.During destructive testing, it was identified that the turbine was corroded, indicating the presence of dried saline within the device.It was considered likely that the presence of dried saline interfered with the device's ability to rotate, leading to a device stall.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18295932
• Report Number: 2124215-2023-69426
• Device Sequence Number: 7438154
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 01/10/2024

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: 02/27/2025
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0031139671
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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