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

Model Number 3243

Device Problems Entrapment of Device (1212); Gas/Air Leak (2946); Intermittent Loss of Power (4016)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.During a percutaneous coronary intervention (pci) procedure, a rotapro 2.00mm and rotawire were selected to treat a 99% stenosed, moderately calcified and moderately tortuous lesion within the right coronary artery (rca).Following a stall of the burr, upon removal it was noted the rotapro and rotawire were stuck together and were removed as one unit.The procedure was completed and no patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device found that blood was present within the sheath and advancer.Functional testing was performed with the returned rotawire.During functional testing, the returned rotawire was able to be removed with severe resistance, but was not able to be reinserted into the rotapro device due to the presence of blood within the device.Further functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was not able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch (ablation button) was pressed, the device stalled and would not run due to the blood within the sheath and advancer.The sound of air escaping the device could be heard during the device stall.Product analysis confirmed the reported events, as the presence of blood within the device prevented reinsertion of the rotawire, and lead to a stall error where air was heard escaping the device.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15819690
• MDR Text Key: 305515701
• Report Number: 2124215-2022-47764
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

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 Expiration Date: 02/16/2023
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0026814422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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 Sex: Male