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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.25mm rotalink burr was selected for used.Upon device loading, a restriction was felt in the burr tip and the catheter shaft.During the procedure, the speed was set to 180000 rpm.It was noted that the advancer was leaking gas; the burr stalled, and the burr tip became stuck in the lesion.The maximum speed reached was 160000 rpm.The burr catheter was removed separately from the guidewire, by switching the speed from high to low speed, and moving the burr forward and backward, before exiting.The procedure was completed with another of the same device.No complications were reported, and patient condition was stable post procedure.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.25mm rotalink burr was selected for used.Upon device loading, a restriction was felt in the burr tip and the catheter shaft.During the procedure, the speed was set to 180000 rpm.It was noted that the advancer was leaking gas; the burr stalled, and the burr tip became stuck in the lesion.The maximum speed reached was 160000 rpm.The burr catheter was removed separately from the guidewire, by switching the speed from high to low speed, and moving the burr forward and backward, before exiting.The procedure was completed with another of the same device.No complications were reported, and patient condition was stable post procedure.
Additional Manufacturer Narrative
E1: (b)(6).Device evaluated by manufacturer: a visual inspection found that the coil was kinked and stretched at the handshake connection.At 14cm distal from the strain relief, the sheath was torn.The coil was stretched for a length of 6cm, 25cm distal from the proximal end of the handshake connection, same location as the torn sheath.The tip of the sheath was found to be damaged.Microscope inspection of the device found no damages or irregularities.Photo media shows a portion of the burr catheter; however, due to visibility, the reported events could not be confirmed, and no damage is detected from the photo provided.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital.E1 initial reporter phone:(b)(6).H6 device code: corrected.Device evaluated by manufacturer: a visual inspection found that the coil was kinked and stretched at the handshake connection.At 14cm distal from the strain relief, the sheath was torn.The coil was stretched for a length of 6cm, 25cm distal from the proximal end of the handshake connection, same location as the torn sheath.The tip of the sheath was found to be damaged.Microscope inspection of the device found no damages or irregularities.Photo media shows a portion of the burr catheter; however, due to visibility, the reported events could not be confirmed, and no damage is detected from the photo provided.
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.25mm rotalink burr was selected for used.Upon device loading, a restriction was felt in the burr tip and the catheter shaft.During the procedure, the speed was set to 180000 rpm.It was noted that the advancer was leaking gas; the burr stalled, and the burr tip became stuck in the lesion.The maximum speed reached was 160000 rpm.The burr catheter was removed separately from the guidewire, by switching the speed from high to low speed, and moving the burr forward and backward, before exiting.The procedure was completed with another of the same device.No complications were reported, and patient condition was stable post procedure.

• 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: 22311612
• Report Number: 2124215-2025-37842
• Device Sequence Number: 15690310
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)250820(10)32255623
• 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): 12/23/2025

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: 08/20/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032255623
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 11/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/21/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 78 KG