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

Model Number 39467-125

Device Problem Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 03/08/2024

Event Type  Death  

Event Description

It was reported that the patient died.The target lesion was located in the heavily calcified left main (lm) and left anterior descending (lad) artery.A 1.25mm rotapro was used to treat patient with worsening heart failure admitted post percutaneous old balloon angioplasty (poba) completed at another hospital.The patient was admitted with cardiogenic shock and acute pulmonary oedema (apo).Balloon aortic valvuloplasty (bav) was to be completed initially and then treatment to the lm and lad lesions with rotablation.Right circumflex femoral artery (rcfa) access was obtained as well as right circumflex femoral vein (rcfv).Temporary pacing wire (tpw) was positioned at the right ventricle apex and pacing capture was confirmed.Bav was performed with stable diastolic blood pressure and rhythm and the tpw was withdrawn.The lad lesion was then initially crossed with a non-boston scientific (bsc) wire and exchanged for a rotawire floppy with aid of a non-bsc microcatheter.Rotational atherectomy was performed with a 1.25mm rotaburr but during the run, the burr became entrapped between two heavily calcified stenoses.The user was unable to withdraw the burr by direct retraction under high-speed rotation, dynaglide or without rotation.Lateral circumflex femoral artery (lcfa) access was then obtained and a second 7fr guide introduced.A non-bsc wire from second guide passed beyond the burr.Multiple balloon dilations were performed at and proximal to the burr to attempt to free but still unable to withdraw the burr.The burr/wire was cut outside the patient and a 7fr non-bsc guide extension catheter was inserted over the burr/wire.Attempted to extract by direct retraction with the aid of guide extension catheter, but still unsuccessful.A snare was passed over the rotawire and further ballooning via second guide.Eventually, the burr was able to be successfully retracted with all of these measures.During this process, the rcfa sheath withdrew from the artery, so the artery was closed with the preclosed prostyle sutures.Angiography (via the lcfa guide) showed focal guide catheter dissection in the lm and a region of dissection in the mid-lad (where the burr had been trapped).The left circumflex (lcx) artery was wired.A synergy 3.0 x 20 mm drug eluting stent (des) was positioned in the mid-lad and deployed at 16 atmospheres (atm).After balloon deflation, a large ellis iii perforation of the lad in the stented region was identified.The balloon was re-inflated to control hemorrhage.Transthoracic echocardiogram (tte) guided pericardiocentesis was performed via sub-costal approach.A 3.0 x 20 mm non-bsc covered stent was placed with successful sealing of the vessel angiographically.Despite pericardiocentesis and stabilization of the perforation, the patient began to decline rapidly, likely due to cumulative ischemia from the interventions.Progressive shock occurred in the patient with poor cardiac reserve and the patient passed away on the cardiac catheterization table.The official cause of death was cardiac tamponade.

• 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 SCIMED, INC; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19093621
• MDR Text Key: 339980531
• Report Number: 2124215-2024-17260
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0032242649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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
• Treatment: GUIDE CATHETER- 7FR EBU 3.5; GUIDEWIRE- WHISPER MS
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 90 YR