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

Model Number 3241

Device Problem Device Damaged by Another Device (2915)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Pericardial Effusion (3271)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported that the rotawire detached, chest pain and pericardial effusion occurred.A 1.25mm rotablator rotalink plus and a rotawire were selected for use during a percutaneous coronary intervention (pci).During the procedure, a non-boston scientific guidewire could not cross the occlusive segment of the proximal right coronary artery (rca).The decision was made to perform rotational atherectomy.Then, a 1.25mm rotablator burr and rotawire were sent to the occlusive segment of the proximal rca for rotational treatment at 150,000 rpm.Due to tortuosity of the blood vessel, the burr leaped forward during the rotation procedure, and it was prompted that the rotawire was fractured.The patient had chest pain at that time, and a little pericardial effusion was observed by color ultrasound.The patient's blood pressure was 180/95mmhg, and he still had chest pain, who was given 3mg morphine injection followed by a subcutaneous injection of 7mg morphine, and the chest pain improved after medication.After 30 minutes of on-stage observation, reexamination of the angiography showed that the local contrast agent staining disappeared, the patient's blood pressure stable, and the chest pain was almost gone.Then, a coronary artery bypass grafting was recommended at a later date.The broken rotawire was removed with surgery.The patient is in stable vital signs after the rescue.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 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: 17740731
• MDR Text Key: 323331297
• Report Number: 2124215-2023-46816
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

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: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0031093334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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