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

Model Number 39467-125

Device Problem Device Damaged by Another Device (2915)

Patient Problems Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/10/2022

Event Type  Injury  

Event Description

It was reported that a wire fracture occurred, followed by a perforation and emergency surgery.The target lesion was located in the mid right coronary artery (rca).A 1.25mm rotapro and a rotawire drive were selected for use.During the procedure, it was noted that the wire was fractured and on the 7th run without advancement, a perforation was observed.A 2.5mm balloon was inflated in the proximal rca to treat the perforation.Other related complications included pericardial effusion, tamponade, st segment elevation, cardiac tamponade, and hypotension.The procedure was not completed.The patient was taken for emergency surgery.A pericardiocentesis was performed and protamine was administered.

Event Description

It was reported that a wire fracture occurred, followed by a perforation and emergency surgery.The target lesion was located in the mid right coronary artery (rca).A 1.25mm rotapro and a rotawire drive were selected for use.During the procedure, it was noted that the wire was fractured and on the 7th run without advancement, a perforation was observed.A 2.5mm balloon was inflated in the proximal rca to treat the perforation.Other related complications included pericardial effusion, tamponade, st segment elevation, cardiac tamponade, and hypotension.The procedure was not completed.The patient was taken for emergency surgery.A pericardiocentesis was performed and protamine was administered.It was further reported that the 95% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.It was confirmed that the perforation was caused by the burr, and a wire fracture was observed following the perforation.The burr was able to be removed, and the distal wire was left in the distal vessel.The patient was stable following surgery.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15852508
• MDR Text Key: 304191482
• Report Number: 2124215-2022-48311
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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 Expiration Date: 03/24/2024
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0029113202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male