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

Model Number	H80222782001A0
Medical Device Problem Codes	Gas/Air Leak (2946); 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
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.During the procedure, it was noted that the advancer was leaking gas, resulting in the complete set of device could not be used.The device was removed.The procedure was not completed due to the same device unavailability.No patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.During the procedure, it was noted that the advancer was leaking gas, resulting in the complete set of device could not be used.The device was removed.The procedure was not completed due to the same device unavailability.No patient complications reported and the patient was stable post procedure.It was further reported that there were no issues with the burr and wire.The burr stalled because of the air leak in the advancer, and the procedure was not completed.Patient was sedated with local anesthesia.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).D6 device codes updated device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device found that the handshake connection was bent.Media depicted a photo showing the bottom of the advancer to the reported complaint batch.However, no evidence to confirm the reported event was provided.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.During the procedure, it was noted that the advancer was leaking gas, resulting in the complete set of devices could not be used.The device was removed.The procedure was not completed due to the same device unavailability.No patient complications reported and the patient was stable post procedure.It was further reported that there were no issues with the burr and wire.The burr stalled because of the air leak in the advancer, and the procedure was not completed.Patient was sedated with local anesthesia.

• 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 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: 22894636
• Report Number: 2124215-2025-58629
• Device Sequence Number: 5986452
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)270124(10)35704391
• 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: H80222782001A0
• Device Catalogue Number: H80222782001A0
• Device Lot Number: 0035704391
• 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: 08/26/2025; 12/05/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/15/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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