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

Model Number	3241
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907); Output Problem (3005)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687)
Date of Event	05/20/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that a death occurred.The 80% stenosed target lesion was located in moderately tortuous and severely calcified left anterior descending (lad) and right coronary artery (rca).Patient was admitted for rotablation procedure for right coronary artery (rca), the surgery had been delayed by weeks as patient had a previous bleed not related to percutaneous coronary intervention (pci) procedure.The patient was frail and high risk for bleeds.A coronary artery bypass grafting (cabg) was not seen as an option.Upon trying to engage the rca, it was challenging, unusual anatomy which lead to ten guides being used but none that would enable adequate support for a rotablator plus.After two hours.The procedure was abandoned with plans to bring the patient back because the hospital did not have a guide on site.The lad was also diseased so the physician progressed with a staged procedure to treat this vessel.A 2.50 emerge balloon was used in the lad then, an intravascular ultrasound (ivus) performed, showed diffuse disease, calcification and a vessel measurements of 3.50mm.A 3.0x12 nc balloon was used, it was unable to get adequate prep of vessel, then they used a 3.0x15mm wolverine balloon, still not getting adequate dilatation of vessel to stent.A non-boston scientific guidewire was exchanged for rotawire.A rotablator plus was prepped and platformed at 180,000rpm outside the patient.Then, a the rotablator plus burr advanced with rotawire into the left main coronary artery (lmca) and to proximal lad.During the first ablation, the rotation speed dropped to 150,000rpm but run was short, around 10 seconds.Then, second ablation went to mid lad where slight tortuous, maybe 30 degree angle and the burr became stuck in lesion.The physician tried to pull out the burr in dynaglide mode, but it was unsuccessful.The patients blood pressure dropped.They were unable to insert another guidewire, so the physician cut the rotablator sheath with scissors.When the guide catheter was removed, the sheath stretched and it came off in sections but was not all removed.The detached burr remained inside the patient.Then, via femoral access the physician advanced a guide extension catheter over rotablator burr shaft, but it was only able to get to the ostium of lmca.The physician tried ballooning proximal to burr with 2.0 balloons and a 1.5x12 over-the-wire (otw) balloon, which was unsuccessful.The patient left the catheterization laboratory (cath lab) and was transferred to the emergency department (ed).Later, the patient was to be transferred to (b)(6) hospital.The patient refused to go to surgery, so, the patient went back into the cath lab to try and retrieve burr again, this was unsuccessful and patient died.
Additional Manufacturer Narrative
Initial reporter state: (b)(6).

• 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: 14680368
• Report Number: 2134265-2022-06416
• Device Sequence Number: 4635565
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0028753491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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; Other; Death
• Patient Sex: Unknown