MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; PROBE, RADIOFREQUENCY LESION

Model Number	CUR-101020U-P
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: n/a upn: cur-101020u-p, model: cur-101020u-p, serial: n/a, batch: 33807643.
Event or Problem Description
It was reported that during the radiofrequency (rf) procedure at the l4 (lumbar) area the needle detached and while attempting to remove it the physician perforated the aorta at the level of the inferior mesenteric artery.An aortic clamping procedure was performed and the patient was hospitalized for two days.The rf procedure was not completed due to this event.The patient is stable.
Event or Problem Description
It was reported that during the radiofrequency (rf) procedure at the l4 (lumbar) area the needle detached and while attempting to remove it the physician perforated the aorta at the level of the inferior mesenteric artery.An aortic clamping procedure was performed and the patient was hospitalized for two days.The rf procedure was not completed due to this event.The patient is stable.Additional information was received that only one device was involved.The patient is doing well post operatively.The device will not be returned as it was disposed of by the hospital.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20365269
• Report Number: 3006630150-2024-06634
• Device Sequence Number: 3890211
• Product Code: GXI
• UDI-Device Identifier: 00813250016703
• UDI-Public: 00813250016703
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K082012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CUR-101020U-P
• Device Catalogue Number: CUR-101020U-P
• Device Lot Number: 33807643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/15/2024
• Date Device Manufactured: 04/11/2024
• 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; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male