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

Model Number	3280
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that possible contamination occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A rotalink advancer w/tubular drive shaft was selected for coronary angiography.During preparation, after device was connected, the black knob of the advancer could not move back and forth, and the physician felt that there was foreign body stuck in the device which was not visible to the user.The procedure was completed with another of the same device.No complications were reported and the patient was stable and discharged after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual examination of the device revealed that the drive shaft was displaced within the advancer.Functional testing was performed by toggling/moving the advancer knob back and forth.When toggled, severe resistance was encountered due to the displaced drive shaft.
Event or Problem Description
It was reported that possible contamination occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A rotalink advancer w/tubular drive shaft was selected for coronary angiography.During preparation, after device was connected, the black knob of the advancer could not move back and forth, and the physician felt that there was foreign body stuck in the device which was not visible to the user.The procedure was completed with another of the same device.No complications were reported and the patient was stable and discharged after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual examination of the device was performed and it was believed that the drive shaft was displaced.Further review of the device found that movement of the advancer knob was inhibited by foreign material on the advancer hypotube proximal from the turbine housing and prevented the knob from fully withdrawing proximally.Functional testing was performed by toggling/moving the advancer knob back and forth.When toggled, severe resistance was encountered due to the foreign material on the hypotube.
Event or Problem Description
It was reported that possible contamination occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A rotalink advancer w/tubular drive shaft was selected for coronary angiography.During preparation, after device was connected, the black knob of the advancer could not move back and forth, and the physician felt that there was foreign body stuck in the device which was not visible to the user.The procedure was completed with another of the same device.No complications were reported and the patient was stable and discharged after the procedure.

• Brand Name: ROTALINK ADVANCER
• Common Device Name: CATHETER, CORONARY, 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 19310011
• Report Number: 2124215-2024-28892
• Device Sequence Number: 6911612
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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: 06/18/2024
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0029793189
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 01/07/2026
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/15/2024; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 60 KG