MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3560
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment of the device occurred resulting in unretrieved device fragment.The 95% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.25mm rotapro and a rotawire were selected for treatment to the lesion.During advancement there was a large bend in the anatomy and significant resistance was encountered at the lesion.Rotational speed was set to 230,000 rmp.The 1.25mm rotapro burr and the rotawire detached while it was ablating the lesion.No surgical treatment was performed due to the patient blood flow was secured.The detached burr was left inside the body.Both device were able to be recovered.The procedure has been cancelled.Percutaneous coronary intervention or bypass will be considered for future treatment.No further patient complications were reported and the patient remained stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a rotawire ic device.The proximal end, wire body, and distal end were visually and microscopically examined.Visual and microscope inspection of the analysis of the returned product revealed that the rotawire was fractured at the spring tip.The fractured portion of the device was not returned for analysis.The damage to the annulus was found to be consistent with continuous interaction between the rotawire and the rotating burr, most closely resembling a wear fracture.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that detachment of the device occurred resulting in unretrieved device fragment.The 95% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.25mm rotapro and a rotawire were selected for treatment to the lesion.During advancement there was a large bend in the anatomy and significant resistance was encountered at the lesion.Rotational speed was set to (b)(4).The 1.25mm rotapro burr and the rotawire detached while it was ablating the lesion.No surgical treatment was performed due to the patient blood flow was secured.The detached burr was left inside the body.Both device were able to be recovered.The procedure has been cancelled.Percutaneous coronary intervention or bypass will be considered for future treatment.No further patient complications were reported and the patient remained stable.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14733889
• Report Number: 2134265-2022-06999
• Device Sequence Number: 2215001
• Product Code: MCX
• UDI-Device Identifier: 08714729144168
• UDI-Public: 08714729144168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/05/2022

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: 03/15/2023
• Device Model Number: 3560
• Device Catalogue Number: 3560
• Device Lot Number: 0026975365
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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: Other
• Patient Sex: Unknown