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

Model Number 39467-125

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3 - date of event: date of event was approximated to 09/01/2023 as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection found that the burr was detached, and that the coil was stretched and detached.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.The rotapro advancer was then connected to the rotapro control console system.The advancer was able to reach optimum speed without stalling.During functional testing there was no abnormalities to the device, and it ran with no speed or noise issues.The advancer was able to reach optimum speed without abnormal noises during analysis.As the burr and coil were found to be damaged, it was considered likely that the abnormal noises heard during the procedure were attributable to the separation of the coil from the burr.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 16jan2024.It was reported that the burr sounded abnormal.A 1.25mm rotapro was selected for use.During platform testing, it was noted that the burr did not sound right.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the burr and coil were detached.

• Brand Name: ROTAPRO
• Type of Device: 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: 18627503
• MDR Text Key: 334389595
• Report Number: 2124215-2024-02277
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0030630775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1