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

Model Number	3320
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978); Mechanical Jam (2983); Output Problem (3005); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter saline leak occurred.The target lesion was located in the radial artery.A 1.50mm rotalink burr was selected for use.During the procedure, there was a rupture at the proximal end of the catheter, and the water leakage was serious, resulting in no water flow from the tip of the catheter, a decrease in speed, and friction with the guide wire.The procedure was completed with another of the same device.No complications were reported, and patient is stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by manufacturer.The complaint device was received for product analysis.Visual inspection of the device found that at 20.4cm distal from strain relief, the sheath was kinked.The rotawire was able to be removed from both devices with great resistance due to severe kink damage on the wire.The damage to the wire prevented reinsertion.Microscopic inspection of the device found that at 20.4cm distal from strain relief, the sheath was torn.The coil was in good condition despite severity of damage present to the sheath.Media provided depicted a saline leak near the middle of the sheath, with evidence of saline pressure as the tip of the sheath still had saline flow but was minimal.The media provided confirms the reported leak and aligns to the damage found in device analysis.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that catheter saline leak occurred.The target lesion was located in the radial artery.A 1.50mm rotalink burr was selected for use.During the procedure, there was a rupture at the proximal end of the catheter, and the water leakage was serious, resulting in no water flow from the tip of the catheter, a decrease in speed, and friction with the guide wire.The procedure was completed with another of the same device.No complications were reported, and patient is 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: 21618782
• Report Number: 2124215-2025-15310
• Device Sequence Number: 15160402
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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
• Report Date (Section B): 05/21/2025

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: 0035106783
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 62 KG