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

Model Number	39467-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck in lesion.The target lesion was located in the very tight calcified artery.A 1.50 mm rotapro was selected for use.During the procedure, the rotapro burr got stuck in the lesion and was cut to release.The burr was recovered using a guidezilla 8fr catheter.The procedure was completed using another of the same device and a non-boston scientific device.There were no patient complications reported.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).C2/d10 - concomitant product/therapy (1): corrected.Device evaluated by mfr: the complaint device was received for product analysis.A visual examination of the device found that the coil was detached 2.2cm in length from the distal end of the coil.The burr failed to return for further analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the burr became stuck in lesion.The target lesion was located in the very tight calcified artery.A 1.50 mm rotapro was selected for use.During the procedure, the rotapro burr got stuck in the lesion and was cut to release.The burr was recovered using a guidezilla 8fr catheter.The procedure was completed using another of the same device and a non-boston scientific device.There were no patient complications reported.

• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20544288
• Report Number: 2124215-2024-67263
• Device Sequence Number: 7459412
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/26/2024

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 Expiration Date: 08/07/2026
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0034587582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BURR/ADVANCER - 1.50MM ROTAPRO; GUIDE CATHETER EXTENSION - GUIDEZILLA 8FR; GUIDE CATHETER EXTENSION - GUIDEZILLA 8FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown