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

Device Problem Device Damaged by Another Device (2915)

Patient Problems Cardiac Arrest (1762); Perforation (2001); Foreign Body In Patient (2687)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that a guidewire fracture occurred.A rotapro and rotawire were being used for treatment during a rotational atherectomy procedure.During the procedure, a rotawire and rotapro were advanced to the target lesion.As the burr approached, it stopped in the left main coronary artery (lm).During the next attempt of ablation, the rotapro burr unexpectedly fractured the rotawire and perforated the lm.Following this, the patient experienced cardiac arrest and cardiopulmonary resuscitation maneuvers were initiated.A non-bsc stent was then advanced in order to cover the dissection successfully, however the fractured piece of rotawire was not able to be retrieved from the patient.Following this event, the patient had fully recovered.

Manufacturer Narrative

B3, (b)(6) 2022 was selected as an approximate date of event.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LTD; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17472392
• MDR Text Key: 320567022
• Report Number: 2124215-2023-41763
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male