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

Model Number	3320
Medical Device Problem Codes	Leak/Splash (1354); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device leak occurred.The patient presented with ischemic heart disease.The target lesion was located in the severely calcified coronary artery.A 1.25mm rotalink burr was selected for percutaneous coronary intervention (pci).During speed test, upon connection, the system had abnormal sound, it was noted that the device was leaking fluid.The device was removed intact along with the rotawire.The procedure was completed with another rotapro device.There was no patient complications reported.
Event or Problem Description
It was reported that a device leak occurred.The patient presented with ischemic heart disease.The target lesion was located in the severely calcified coronary artery.A 1.25mm rotalink burr was selected for percutaneous coronary intervention (pci).During speed test, upon connection, the system had abnormal sound, it was noted that the device was leaking fluid.The device was removed intact along with the rotawire.The procedure was completed with another rotapro device.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotalink burr atherectomy catheter.Visual inspection of the device did not identify any damages or defects.A test advancer was used as the advancer used during the procedure was not returned for analysis.When the returned burr catheter was connected to the test advancer, and the test advancer was connected to the fluid infusion line, there were no abnormal fluid leaks noted from the device.A steady drip of fluid from the distal end of the catheter was seen as intended by design.When the test advancer was connected to the rotapro console and the knob switch [ablation button] was pressed, the returned burr catheter was able to reach and maintain optimal rpm with no resistance or issues using the test advancer.There were no abnormal noises heard during test rotation.

• Brand Name: ROTALINK BURR
• 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: 20737525
• Report Number: 2124215-2024-70807
• Device Sequence Number: 8297851
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 09/05/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032365129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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
• Patient Sex: Unknown