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

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

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

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

B3: date of event: estimated based upon the aware date as the event date was not provided."s54-4 (case1) rotablator burr entrapment: factors and bail out techniques" was on a poster presentation at a conference on complication cases from all over asia, friday, (b)(6) 2023, in fukuoka, japan.

Event Description

It was reported that the burr became stuck in the lesion requiring additional intervention.The severely stenosed target lesion was located in the calcified right coronary artery (rca).Ablation was initiated with a 2.0 mm rotablator, but it failed to pass the lesion.The burr was exchanged for a 1.50 mm burr and passage was successful.The 2.0 mm burr was again used, but became stuck in the distal rca lesion.The proximal shaft was cut and a guide-extension catheter was used for better back up and co-axiality, but the burr could not be retrieved.An additional guide catheter was inserted and a slippery guidewire was advanced to cross the lesion.After dilation of 2.00 mm and 3.00 mm balloons beside the burr, the guide-extension catheter could be advanced and the burr was retrieved successfully.

• 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): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17705509
• MDR Text Key: 322924303
• Report Number: 2124215-2023-48905
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention