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

Model Number 39467-125

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that a hole in the sheath occurred.Two rotapro atherectomy catheters (1.25mm and 1.50mm) were selected for treatment to a 80-90% stenosed circumflex artery.During ablation a saline leak was observed on the sheath of both catheters.The procedure was completed with these devices.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device found that the sheath was damaged at 19cm to 21cm distal of the burr housing strain relief.The damage was inspected and found to be most evident of pinching.Functional testing was performed by connecting the rotapro device to the liquid infusion line.When liquid was advanced through the device, a leak was identified at the damaged portion of the sheath in accordance with the reported events.

Event Description

It was reported that a hole in the sheath occurred.Two (2) rotapro atherectomy catheters (1.25mm and 1.50mm) were selected for treatment to a 80-90% stenosed circumflex artery.During ablation a saline leak was observed on the sheath of both catheters.The procedure was completed with these devices.No patient complications were reported.

• 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: 15544916
• MDR Text Key: 304345678
• Report Number: 2124215-2022-39842
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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: 05/05/2023
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0027258883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1