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

Model Number 2077-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2023

Event Type  Death  

Event Description

Reported via user facility # (b)(4).It was reported that the wire tip broke, was snared but remained in patient, and patient expired.A rotawire drive was selected for use.Patient was transferred to facility for cardiac catheterization.Cardiac catheterization showed lima (left internal mammary artery) to lad (left anterior descending artery) was patent and native right coronary artery had a subtotal in-stent restenosis in the proximal segment.Balloon angioplasty followed by rotational atherectomy was performed.The procedure was complicated by rotafloppy wire breaking off at the tip and remaining in the distal right coronary artery/right pda (posterior descending artery).Multiple attempts were made with snare, double wire technique to retrieve the wire.This was complicated by the wires getting pinned in the native right coronary artery with occlusion of the right coronary artery leading to acute inferior myocardial infarction.Surgical consult was obtained for emergency salvage bypass surgery and retrieval of retained wire.Given unstable condition with acute inferior myocardial infarction, patient being on antiplatelet therapy and being a p2 sternotomy, he was considered high risk.Surgical consult with vascular surgery was obtained to see if the retained wires could be retrieved through brachial cutdown approach, which was attempted.Patient became hemodynamic requiring intubation, cpr pressor support.Despite multiple efforts they were unable to resuscitate the patient.Finally, after discussion with the family resuscitation efforts were discontinued.Patient expired at 10:30 pm.

• Brand Name: ROTAWIRE DRIVE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18389255
• MDR Text Key: 331283283
• Report Number: 2124215-2023-72998
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056/S166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2023

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
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0031221120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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): Death; Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: Black Or African American