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

Model Number 39467-125

Device Problem Output Problem (3005)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Perforation of Vessels (2135)

Event Date 04/10/2024

Event Type  Injury  

Event Description

It was reported that a vessel perforation occurred.The target lesion was located in the tortuous and heavily calcified proximal to middle circumflex artery (cx).A 1.25mm rotapro was selected for complex percutaneous coronary intervention (pci) procedure.The patient does not want a surgery, so the physician agreed to attempt this complex pci.During the procedure, multiple compliant balloons were inflated before attempting to directly deliver the rotawire drive to the vessel, but it was unsuccessful.A wire exchange was performed and then the 1.25mm rotapro was advanced to lesion.Ablation was performed and the physician was very cautious but had good pecking motion and did runs of around 10 to 15 seconds at 180,000rpm.Decelerations were noted and pathway was being created it was noted slight leaking of contrast observed.There was a bend at the distal section of lesion, which the physician feels was the cause of the perforation.Consequently, the patient experienced ecg changes and chest pain.A nc balloon was inflated and then covered stent placed to treat the perforation.The procedure completed without further issues.The patient was stable post procedure and expected to fully recover.

• 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 CORPORATION; 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: 19208375
• MDR Text Key: 341356660
• Report Number: 2124215-2024-22445
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P900056
• 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: 04/29/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0032356131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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): Required Intervention
• Patient Sex: Male