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

Model Number	3243
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Ischemia (1942); Myocardial Infarction (1969)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device was difficult to advance and ischemia, and myocardial infarction occurred.During a percutaneous coronary intervention (pci), the rotapro was difficult to advance and the knob did not have smooth movement.The device was replaced to resolve the issue.Ischemia and myocardial infarction was noted in the patient, during the device issue.No further complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Correction: (h6) patient code addition.Device evaluated by manufacturer: the returned product consisted of the rotapro atherectomy system.The burr catheter was connected to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.The advancer knob switch was in the backwards position when received and experienced resistance when attempting to move into the forward position.The housings were disconnected, and it was revealed the coil was kinked and stretched at the burr handshake connection.The knob switch was able to move back and forth with no resistance while the housings were disconnected.Product analysis confirmed the reported events, as the kinked and stretched coil caused resistance when attempting to move the advancer knob forward.
Event or Problem Description
It was reported the device was difficult to advance and ischemia, and myocardial infarction occurred.During a percutaneous coronary intervention (pci), the rotapro was difficult to advance and the knob did not have smooth movement.The device was replaced to resolve the issue.Ischemia and myocardial infarction was noted in the patient, during the device issue.No further complications reported and the patient was stable post procedure.

• Brand Name: ROTAPRO
• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16991976
• Report Number: 2124215-2023-25902
• Device Sequence Number: 15220685
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2025
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031085633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Patient Sex: Unknown