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

Model Number	3320
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was fractured.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left main artery.A 2.00mm rotalink burr and a 330cm rotawire guidewire was selected for use.During the procedure, it was noted that the guidewire was fractured when used along with 2.00mm rotalink burr.According to the physician, the fracture was due to the lesion characteristics.The device was completely removed via normal method and the procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the catheter was fractured.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left main artery.A 2.00mm rotalink burr and a 330cm rotawire guidewire was selected for use.During the procedure, it was noted that the guidewire was fractured when used along with 2.00mm rotalink burr.According to the physician, the fracture was due to the lesion characteristics.The device was completely removed via normal method and the procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotablator rotalink burr catheter.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the coil was kinked and stretched at the handshake connection, but no device fractures were identified.Product analysis did not confirm the reported event, as there were no fracture damages identified to the device.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55311 ; 6515810888
• MDR Report Key: 14245112
• Report Number: 2134265-2022-04848
• Device Sequence Number: 4421251
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0027155565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG