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

Model Number 39467-175

Device Problem Break (1069)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

It was reported that a device separation occurred.A 1.75mm rotapro was selected for use.During the procedure, it was noted that the drive shaft was separated.The device was removed together with the guiding catheter.Additionally, when the burr has been removed outside the body, it was found out that the wire was also separated.The wire was removed using a gooseneck snare.The procedure was completed with the original device.There were no patient complications reported post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received with the burr separated.The rotawire used in the procedure was returned through complaint (b)(4).The burr was received on the returned rotawire.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil had been stretched and broken at the point of detachment from the burr.Product analysis confirmed the reported event, as the burr was received detached from the coil, and the coil was stretched and broken at the point of detachment.

Event Description

It was reported that a device separation occurred.A 1.75mm rotapro and rotawire drive were selected for use.During the procedure, it was noted that the drive shaft was separated.The device was removed together with the guiding catheter.Additionally, when the burr has been removed outside the body, it was found out that the wire was also separated.The wire was removed using a gooseneck snare.The procedure was completed with the original device.There were no patient complications reported post procedure.

• 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 ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16665315
• MDR Text Key: 312593514
• Report Number: 2124215-2023-13361
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• 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: 0030793250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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