MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLOIST; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36703
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating was coming off the tip.A soloist needle electrode was selected for use in a radio frequency ablation procedure of an osteoid osteoma in the femoral bone.While unpacking the device, it was observed that the soloist had a defect in insulation, and the plastic coating was coming out from the tip of the needle.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: patient is under 18 years old device/media analysis by manufacturer: the device was not returned for analysis; however, a photo was provided and it was possible to observe the insulation sheath distal section.Additionally, it was possible to observe that the sheath was damaged.
Additional Manufacturer Narrative
A2: age at time of event: patient is under 18 years old.Device/media analysis by manufacturer: the device was not returned for analysis; however, a photo was provided and it was possible to observe the insulation sheath distal section.Additionally, it was possible to observe that the sheath was damaged.One electrode needle was returned inside the insulation sheath for analysis and its respective connection cable.The insulation sheath was damaged at the distal section.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.Resistance between the electrode and corresponding tine was within specification.
Event or Problem Description
It was reported that the coating was coming off the tip.A soloist needle electrode was selected for use in a radio frequency ablation procedure of an osteoid osteoma in the femoral bone.While unpacking the device, it was observed that the soloist had a defect in insulation, and the plastic coating was coming out from the tip of the needle.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SOLOIST
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15375304
• Report Number: 2124215-2022-34661
• Device Sequence Number: 5567235
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: 08714729122487
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K053128
• 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): 11/21/2022

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: 01/25/2025
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0028768923
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Male