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

Model Number	3320
Medical Device Problem Codes	Nonstandard Device (1420); 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	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A 1.50mm rotalink burr was selected for use.During the procedure, the whole set of single-use device could not be used normally due to the advancer was leaking gas.The procedure was cancelled.There were no complications, and patient was stable post procedure.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.
Event or Problem Description
It was reported that the procedure was cancelled.A 1.50mm rotalink burr was selected for use.During the procedure, the whole set of single-use device could not be used normally due to the advancer was leaking gas.The procedure was cancelled.There were no complications, and patient was stable post procedure.It was further reported that there were no issues with the rotalink burr, and that the patient was sedated with local anesthesia.
Event or Problem Description
It was reported that the procedure was cancelled.A 1.50mm rotalink burr was selected for use.During the procedure, the whole set of single-use device could not be used normally due to the advancer was leaking gas.The procedure was cancelled.There were no complications, and patient was stable post procedure.It was further reported that there were no issues with the rotalink burr, and that the patient was sedated with local anesthesia.It was further reported that the burr stalled due to the advancer leak.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the coil was kinked and stretched at the handshake connection.A media depicted a photo showing the bottom of the (related) advancer to bsc; however, no evidence to confirm the reported event was provided.No other issues were identified during the product analysis.E1-initial reporter phone: (b)(6).

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22916812
• Report Number: 2124215-2025-59890
• Device Sequence Number: 9676535
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: (01)08714729185857(17)270218(10)35882422
• 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): 12/31/2025

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 Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0035882422
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 12/09/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/24/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 120 KG