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

Model Number 3241

Device Problems Entrapment of Device (1212); Output Problem (3005); Intermittent Loss of Power (4016)

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

Event Date 11/24/2023

Event Type  malfunction  

Event Description

It was reported that the burr became stuck in the lesion.The target lesion was located in the stenosed left anterior descending artery (lad).A 1.25mm rotablator rotalink plus was selected for use.During the procedure, it was noted that the device suddenly lost its speed when it ran over 150,000rpm and the device stalled; the burr became stuck in the lesion.The device was withdrawn directly along with the guidewire.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.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

It was reported that the burr became stuck in the lesion.The target lesion was located in the stenosed left anterior descending artery (lad).A 1.25mm rotablator rotalink plus was selected for use.During the procedure, it was noted that the device suddenly lost its speed when it ran over 150,000rpm and the device stalled; the burr became stuck in the lesion.The device was withdrawn directly along with the guidewire.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.

• 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 CORK LIMITED; 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: 18536087
• MDR Text Key: 333150396
• Report Number: 2124215-2023-74303
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 03/04/2024

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: 12/25/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0028737646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 89 KG