MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3243
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of an incomplete rotapro atherectomy system as the burr and distal portions of the coil and sheath failed to return for further analysis.Inspection of the device found that the burr catheter was received attached to the advancer via handshake connection.The burr housing and sheath were returned separate from the handshake connection and coil to the burr catheter.The sheath was separated at 9.7cm distal from the strain relief.The total returned portion of the coil was 24.9cm from the proximal end of the handshake connection to the burr catheter.Analysis found that the coil and sheath were detached, and the coil was severely stretched.During advancer testing, the device stalled during analysis, to which it was discovered that the device had a corroded turbine, and the shutter was damaged.The corroded turbine is not an expected factor during use of the device within the procedure.The shutter damage present could interfere with the devices ability to maintain optimal speed.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that device stalled.A 1.50mm rotapro was selected for use.During preparation prior to procedure the rotapro was not working well and showing red stall indicator error.Procedure was completed using another device and no patient complications were reported.However, device analysis revealed that catheter coil and sheath were detached/separated.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20313729
• Report Number: 2124215-2024-59471
• Device Sequence Number: 7679061
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: 05/11/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031605283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Patient Sex: Unknown