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

Model Number 3243

Device Problems Device Contamination with Body Fluid (2317); Output Problem (3005); Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/26/2023

Event Type  Injury  

Manufacturer Narrative

Initial report phone: (b)(6).

Event 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.

Manufacturer Narrative

D4 lot#: 0029142529.E1 initial report phone: (b)(6).

Event 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.

Manufacturer Narrative

E1 initial report phone: +011(002)01221092711.

Event 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
• Type of Device: 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
• MDR Text Key: 311202755
• Report Number: 2124215-2023-11797
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/19/2023; 07/12/2023
• Supplement Dates FDA Received: 04/12/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 82 KG