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

Model Number	3243
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Output Problem (3005); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report phone: (b)(6).
Event or Problem Description
It was noted that the device was leaking blood.Vascular access was obtained via the right femoral artery.The 80% stenosed, 22mm in length, concentric, de novo (progression) target lesion was located in the severely tortuous and mildly calcified left anterior descending artery (lad).A 1.75mm rotapro was selected for use.During the procedure, upon advancing in the left main and proximal lad, starting with a high-speed rotation with a procedural target of 160,000rpm, the maximum rotation speed reached at 162,000rpm.It was then noted that blood and air was coming out in the advancer, just beneath the advancer knob.There was decline in vital signs as a result of blood loss but was quickly injected with atropine.The whole system was removed from the patient, and it was noted there was a tear in the rota sheath.The procedure was completed with a different device.No further complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
D4 lot#: 0029142529.E1 initial report phone: (b)(6).
Event or Problem Description
It was noted that the device was leaking blood.Vascular access was obtained via the right femoral artery.The 80% stenosed, 22mm in length, concentric, de novo (progression) target lesion was located in the severely tortuous and mildly calcified left anterior descending artery (lad).A 1.75mm rotapro was selected for use.During the procedure, upon advancing in the left main and proximal lad, starting with a high-speed rotation with a procedural target of 160,000rpm, the maximum rotation speed reached at 162,000rpm.It was then noted that blood and air was coming out in the advancer, just beneath the advancer knob.There was decline in vital signs as a result of blood loss but was quickly injected with atropine.The whole system was removed from the patient, and it was noted there was a tear in the rota sheath.The procedure was completed with a different device.No further complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
E1 initial report phone: +011(002)01221092711.
Event or Problem Description
It was noted that the device was leaking blood.Vascular access was obtained via the right femoral artery.The 80% stenosed, 22mm in length, concentric, de novo (progression) target lesion was located in the severely tortuous and mildly calcified left anterior descending artery (lad).A 1.75mm rotapro was selected for use.During the procedure, upon advancing in the left main and proximal lad, starting with a high-speed rotation with a procedural target of 160,000rpm, the maximum rotation speed reached at 162,000rpm.It was then noted that blood and air was coming out in the advancer, just beneath the advancer knob.There was decline in vital signs as a result of blood loss but was quickly injected with atropine.The whole system was removed from the patient, and it was noted there was a tear in the rota sheath.The procedure was completed with a different device.No further complications were reported, and patient was stable post procedure.

• 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 SCIMED, INC; model farm road; cork MN ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16535118
• Report Number: 2124215-2023-11797
• Device Sequence Number: 12343535
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 08/01/2023

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: 03/30/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0029142529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/19/2023; 07/12/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/12/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 82 KG