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

Model Number 3243

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

It was reported that a shaft leak occurred: a rotapro 1.25mm atherectomy catheter was selected for use.Rotablation was performed normally.Three fourths of the stenosis was treated then the rotapro 1.25mm pressure decreased.The rotapro 1.25mm was removed from the patient and a leak was observed on the side of the catheter where flushing solution come out.The procedure was completed via an alternative method.No patient harm resulted in relation to this event.

Manufacturer Narrative

Initial reporter city - (b)(6).

Manufacturer Narrative

E1: initial reporter city = (b)(6).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 pinched/damaged at 22cm from the burr housing strain relief.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.Product analysis confirmed the reported event, as the sheath was damaged and leaking in accordance with the reported events.

Event Description

It was reported that a shaft leak occurred: a rotapro 1.25mm atherectomy catheter was selected for use.Rotablation was performed normally.Three fourths of the stenosis was treated then the rotapro 1.25mm pressure decreased.The rotapro 1.25mm was removed from the patient and a leak was observed on the side of the catheter where flushing solution come out.The procedure was completed via an alternative method.No patient harm resulted in relation to this event.

• 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 ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16529476
• MDR Text Key: 311157335
• Report Number: 2124215-2023-11495
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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: 02/02/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0028793476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• 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