MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).

Event Description

It was reported that the procedure was cancelled.The 28mm x 3.0mm in diameter, 95% stenosed target lesion was located in the severely calcified left anterior descending artery (lad).An unknown ce rotablator was selected for use.During the procedure, it was noted that the console was malfunctioning.The procedure was not completed due to this event.There were no complications reported and the patient was stable.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).Correction made due to an update on the ar code and b5.

Event Description

It was reported that the procedure was cancelled.The 28mm x 3.0mm in diameter, 95% stenosed target lesion was located in the severely calcified left anterior descending artery (lad).A 1.50mm rotalink burr and rotalink advancer were selected for use.During the procedure, it was noted that the console was malfunctioning.The procedure was not completed due to this event.There were no complications reported and the patient was stable.It was further reported that the patient was sedated with local anesthesia.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18194203
• MDR Text Key: 328824262
• Report Number: 2124215-2023-63893
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/01/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG