MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

Event Description

It was reported that a rotawire detached and remained inside the patient and a perforation occurred.A rotapro and rotawire were selected for use for a procedure.After five ablation performed, the rotawire broke inside the patient due to the lesion steep bent was 90 degrees.It was noticed that the rotapro burr perforated the right coronary artery (rca).Then, the physician succeeded to rewire the vessel and they succeeded to deliver two stents.The detached rotawire remained in the artery and was stented toward the vessel wall.The patient was fine post procedure.

Manufacturer Narrative

B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

Event Description

It was reported that a rotawire detached and remained inside the patient and a perforation occurred.A rotapro and rotawire were selected for use for a procedure.After five ablation performed, the rotawire broke inside the patient due to the lesion steep bent was 90 degrees.It was noticed that the rotapro burr perforated the right coronary artery (rca).Then, the physician succeeded to rewire the vessel and they succeeded to deliver two stents.The detached rotawire remained in the artery and was stented toward the vessel wall.The patient was fine post procedure.It was further reported the target lesion was located in the severely tortuous and severely calcified right coronary artery.The actual and procedural speed was 160k.There was no significant resistance encountered between the burr and rotawire.A portion of the detached rotawire was able to be pulled out of the patient.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13111733
• MDR Text Key: 282919462
• Report Number: 2134265-2021-16288
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P900056
• 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,Followup
• Report Date: 01/19/2022

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
• Device Model Number: H802228240022
• Device Catalogue Number: 3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/19/2022
• 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; Other