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	Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiogenic Shock (2262)
Date of Event	12/03/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient death occurred.The patient presented for a complex left main to left anterior descending artery (lad) crossover procedure.It was noted that the left main was severely tortuous and heavily calcified.A 1.75mm rotalink rotablator plus was used for two runs of 11 seconds to ablate the calcium, then a wolverine 3.0 x 10mm and a synergy 3.0 x 32mm were used to treat the lesion; both were inflated at 11 atm.Afterwards, angio revealed timi3 flow without any dissection.After angio, however, the patient went into cardiac arrest and was immediately moved for emergency coronary artery bypass graft surgery.The patient passed away the next day due to cardiac tamponade which led to cardiogenic shock.
Event or Problem Description
It was reported that a patient death occurred.The patient presented for a complex left main to left anterior descending artery (lad) crossover procedure.It was noted that the left main was severely tortuous and heavily calcified.A 1.75mm rotalink rotablator plus was used for two runs of 11 seconds to ablate the calcium, then a wolverine 3.0 x 10mm and a synergy 3.0 x 32mm were used to treat the lesion; both were inflated at 11 atm.Afterwards, angio revealed timi3 flow without any dissection.After angio, however, the patient went into cardiac arrest and was immediately moved for emergency coronary artery bypass graft surgery.The patient passed away the next day due to cardiac tamponade which led to cardiogenic shock.
Additional Manufacturer Narrative
The returned product consisted of the rotablator atherectomy system.A visual inspection of the device revealed that the coil was kinked and stretched at the handshake connection.When put through a functional test, the device would stall and not run.Destructive testing was done along with microscopic examination.This revealed that the shutter was damaged which could lead to fiberoptic interference.Design assurance and cork supplier quality were contacted regarding the shutter damage, and it was verified that the shutter damage present was likely due to a molding defect from the supplier.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.

• Brand Name: ROTALINK PLUS
• Common Device Name: 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: 18415165
• Report Number: 2124215-2023-73963
• Device Sequence Number: 2933157
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2025
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0031714923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Asian