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

Model Number	3241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that myocardial infarction (mi) and st elevation occurred.Vascular access was obtained via the radial artery.The target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery with a 2.75mm vessel diameter.A 1.75mm rotalink plus was selected for use.During the procedure, the physician wanted to do one last round of polishing, however, the patient went into mi and st elevation.The physician removed the device and performed cardiopulmonary resuscitation.The procedure was completed with another of the same device.Patient is stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that myocardial infarction (mi) and st elevation occurred.Vascular access was obtained via the radial artery.The target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery with a 2.75mm vessel diameter.A 1.75mm rotalink plus was selected for use.During the procedure, the physician wanted to do one last round of polishing, however, the patient went into mi and st elevation.The physician removed the device and performed cardiopulmonary resuscitation.The procedure was completed with another of the same device.Patient is stable.It was further reported that the patient regained consciousness after cardiopulmonary resuscitation was performed.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14604116
• Report Number: 2134265-2022-06397
• Device Sequence Number: 6169421
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: MY
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0027558702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown