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

Model Number 3241

Device Problems Break (1069); Output Problem (3005)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the burr shaft was fractured.A 1.50mm rotablator rotalink plus was selected for use.During the pre-procedure (draw) test, it was noted that there was a fracture in the shaft of the device causing it to power down.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The burr catheter was received attached to the advancer unit.Visual inspection revealed that the coil was kinked and stretched at the handshake connection.Device to device interaction testing was performed; the rotalink advancer was connected to the rotablator control console system.When the foot pedal was pressed, the advancer stalled and was not able to run due to the damaged coil.Product analysis confirmed the reported events, as the damaged coil prevented the device from rotating.It was considered likely that the perceived device detachment was attributable to the damage to the coil.

Event Description

It was reported that the burr shaft was fractured.A 1.50mm rotablator rotalink plus was selected for use.During the pre-procedure (draw) test, it was noted that there was a fracture in the shaft of the device causing it to power down.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: ROTALINK PLUS
• 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: 18991432
• MDR Text Key: 338800686
• Report Number: 2124215-2024-17538
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P900056
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0030919246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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