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

Model Number 3243

Device Problems Entrapment of Device (1212); Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported that the guidewire was stuck in the burr.A 1.25 mm rotapro and rotawire and wireclip torquer were selected for use.After regular flushing, a hole was noted in the sheath.Liquid was leaking through the orifice of the pierced sheath.The guidewire became stuck in the burr forcing complete withdrawal.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The rotawire used in the procedure was returned within the rotapro device.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device found that the sheath was torn at 17.5cm from the burr housing strain relief.Functional testing was performed with the returned rotawire.During functional testing, the returned rotawire was able to be removed with resistance, but was not able to be reinserted into the rotapro device due to a kink in the rotawire.In order to determine the functionality of the rotapro device, a test rotawire was used.During analysis, the test rotawire was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.Further functional testing was performed by connecting the rotapro advancer to liquid infusion.During liquid infusion testing, a fluid leak was identified from the torn portion of the sheath.

Event Description

It was reported that the guidewire was stuck in the burr.A 1.25 mm rotapro and rotawire and wireclip torquer were selected for use.After regular flushing, a hole was noted in the sheath.Liquid was leaking through the orifice of the pierced sheath.The guidewire became stuck in the burr forcing complete withdrawal.The procedure was completed with another of the same device.No patient complications were reported.

• 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 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: 18292605
• MDR Text Key: 330127646
• Report Number: 2124215-2023-68386
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031815663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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