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

Model Number 3241

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device found that the coil and sheath were separated at the burr housing strain relief.A catheter kink was not identified.Functional testing was not able to be performed using the returned burr catheter; a test burr catheter was used with the returned advancer.When the rotablator advancer was connected to the rotablator console control system and the foot pedal was pressed, the device reached and maintained optimal rpm with no resistance or issues.

Event Description

Reportable based on the device analysis completed on 26feb2024.It was reported that the device was unable to cross the lesion and catheter got kinked.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.50mm rotablator plus was selected for use.During the procedure, resistance was felt when passing through the lesion and caused the catheter to kink, the burr did not cross the lesion.There were no patient complications were reported.However, device analysis revealed that the coil and sheath were separated at the burr housing strain relief.

• 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: 18932335
• MDR Text Key: 338132745
• Report Number: 2124215-2024-14209
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 0032063825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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