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

Model Number 39467-175

Device Problems Fluid/Blood Leak (1250); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that the rotation speed was unstable.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified first right posterolateral segment (rpl).A 2.00 mm rotapro was selected for use.The rotational speed was set to 180,000 rpm while outside the patient's body, but during advancement to the lesion site the rpm increased to 200,000.It was also noted that a puddle formed underneath the advancer as the burr appeared to leaking more fluid than usual.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.

Event Description

It was reported that the rotation speed was unstable.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified first right posterolateral segment (rpl).A 2.00 mm rotapro was selected for use.The rotational speed was set to 180,000 rpm while outside the patient's body, but during advancement to the lesion site the rpm increased to 200,000.It was also noted that a puddle formed underneath the advancer as the burr appeared to leaking more fluid than usual.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.

Event Description

It was reported that the rotation speed was unstable.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified first right posterolateral segment (rpl).A 2.00 mm rotapro was selected for use.The rotational speed was set to 180,000 rpm while outside the patient's body, but during advancement to the lesion site the rpm increased to 200,000.It was also noted that a puddle formed underneath the advancer as the burr appeared to leaking more fluid than usual.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found no damages or defects.Functional testing was then performed by connecting the advancer to the rotapro control console.During functional testing, the device was able to reach and maintain optimal rpm in both normal and dynaglide modes with no resistance or issues.During test rotation, no abnormal fluid leaks were noted from the device.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18490140
• MDR Text Key: 332986368
• Report Number: 2124215-2023-74541
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/27/2024

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
• Device Operator: Health Professional
• Device Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0031759773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/04/2024; 02/06/2024
• Supplement Dates FDA Received: 01/24/2024; 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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