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

Model Number	CSK-TC10
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the facility that during the sterilization process the central sterilization technician noticed liquid seeping out of the base of the electrode where the probe was attached.This was noticed after the electrode was used in one procedure only.They suspected the liquid was blood as the liquid was red in color and they did not reuse the electrode.
Event or Problem Description
It was reported by the facility that during the sterilization process the central sterilization technician noticed liquid seeping out of the base of the electrode where the probe was attached.This was noticed after the electrode was used in one procedure only.They suspected the liquid was blood as the liquid was red in color and they did not reuse the electrode.
Additional Manufacturer Narrative
The allegation of "having issues with the probe, facility cannot guarantee they are clean as blood continues to come out of the base where the probe is attached" was confirmed.A visual inspection revealed residual foreign material on the hub (near base of the shaft).Material scraped from the electrode tested under atr-ir (ftir) yielded a complex spectrum that suggested a combination of proteins and edta (enzymatic cleaner), but the exact chemistry remains unidentified.A cross section of the electrode revealed that the distal end of the hub was insufficiently filled with epoxy which led to voids inside the hub.The probable cause selected is "manufacturing deficiency" due to the hub being insufficiently filled with epoxy.

• Brand Name: NA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8571591
• Report Number: 3006630150-2019-01990
• Device Sequence Number: 1809788
• Product Code: GXI
• UDI-Device Identifier: 00813250010107
• UDI-Public: 00813250010107
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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 Model Number: CSK-TC10
• Device Catalogue Number: CSK-TC10
• Device Lot Number: Q462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1