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

Model Number 3320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Race: unknown; white.

Event Description

It was reported that the patient experienced ventricular fibrillation requiring additional intervention.The patient presented with severely calcific three-vessel coronary artery disease.The patient was reportedly not a candidate for surgery due to poor distal beds.The physician decided to perform coronary angioplasty with rotational atherectomy to treat the 70% stenosed target lesion located in the moderately tortuous and severely calcified right coronary artery (rca).Prior to the procedure, a temporary pacemaker was implanted as a preventive measure.The lesion was pre-dilated using a 1.50 x 15 mm balloon.Intervention with a 1.50 mm rotalink burr was initiated and moments later the patient experienced ventricular fibrillation, requiring cardiac resuscitation.The patient was stabilized and the procedure continued with a 1.75 mm rotalink burr and balloon angioplasty.A 3.00 x 12 mm synergy stent was introduced, however deformity in its structure was noted during advancement.The stent was removed and replaced with another synergy to complete the procedure with no further complications.The patient was transferred to the intensive care unit and is expected to fully recover.

• Brand Name: ROTALINK BURR
• 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: 18522532
• MDR Text Key: 332974001
• Report Number: 2124215-2023-76042
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 01/16/2024

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: 3320
• Device Catalogue Number: 3320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male