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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Stretched (1601); Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Codes	Discomfort (2330); Vascular Dissection (3160)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6) hospital.
Event or Problem Description
It was reported that the burr became stuck in the lesion and patient underwent surgery.A 70% stenosed target lesion was located in the severely calcified and mildly tortuous ostial circumflex artery.A 1.50 rotaburr was selected for use.During the procedure, resistance was felt when trying to exit the wire through the proximal end of the advancer.Upon removing the wire, it was noted to be a little kinked in the proximal tip of the wire.The bent was modified, and progress was made without problem.Ablation was completed without complications however, the physician noticed that there was resistance.When trying to remove the burr, the guide catheter lost its ostial position in his opinion.The proximal part of the burr was stuck to the aorta and did not allow the guide catheter to be reinserted.They tried to snare without success.Ping pong was attempted with a second wire, managing to channel again successfully, but without success in removing the burr.Other options were stopped, and by-pass surgery was performed.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).H6 - device codes: added detachment of device or device component a0501, stretched a040611, material separation a0413.B5 - describe event or problem: the device was not returned for evaluation.However, an analysis was concluded based on the photo provided by the site showing a detached burr and stretched and detached coil.
Event or Problem Description
It was reported that the burr became stuck in the lesion and patient underwent surgery.A 70% stenosed target lesion was located in the severely calcified and mildly tortuous ostial circumflex artery.A 1.50 rotaburr was selected for use.During the procedure, resistance was felt when trying to exit the wire through the proximal end of the advancer.Upon removing the wire, it was noted to be a little kinked in the proximal tip of the wire.The bent was modified, and progress was made without problem.Ablation was completed without complications however, the physician noticed that there was resistance.When trying to remove the burr, the guide catheter lost its ostial position in his opinion.The proximal part of the burr was stuck to the aorta and did not allow the guide catheter to be reinserted.They tried to snare without success.Ping pong was attempted with a second wire, managing to channel again successfully, but without success in removing the burr.Other options were stopped, and by-pass surgery was performed.
Event or Problem Description
It was reported that the burr became stuck in the lesion and patient underwent surgery.A 70% stenosed target lesion was located in the severely calcified and mildly tortuous ostial circumflex artery.A 1.50 rotaburr was selected for use.During the procedure, resistance was felt when trying to exit the wire through the proximal end of the advancer.Upon removing the wire, it was noted to be a little kinked in the proximal tip of the wire.The bent was modified, and progress was made without problem.Ablation was completed without complications however, the physician noticed that there was resistance.When trying to remove the burr, the guide catheter lost its ostial position in his opinion.The proximal part of the burr was stuck to the aorta and did not allow the guide catheter to be reinserted.They tried to snare without success.Ping pong was attempted with a second wire, managing to channel again successfully, but without success in removing the burr.Other options were stopped, and by-pass surgery was performed.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.E1 - initial reporter address 1: (b)(6) hospital.Device evaluated by mfr: inspection of the device found that the coil was stretched and detached at the burr.The burr was detached and was found returned on the returned on a portion of the incomplete rotawire of which the burr was able to be fully removed with no issue or resistance.Inspection of the device found no further damages or defects.

• Brand Name: ROTAPRO
• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19556960
• Report Number: 2124215-2024-36883
• Device Sequence Number: 6716103
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3243
• Device Catalogue Number: 3243
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 08/22/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/22/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male