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

Model Number	CU-10520U
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the radiofrequency ablation procedure the physician removed the electrode from the patient and saw a piece of metal wire remained in the patients body.An x-ray was performed and found that the whole cu cannula was still sitting in the location where the procedure was performed.A neurosurgeon was called in to perform a surgical procedure in which the cannula wire was removed.The patient has recovered and is doing well post-operatively.
Event or Problem Description
It was reported that during the radiofrequency ablation procedure the physician removed the electrode from the patient and saw a piece of metal wire remained in the patients body.An x-ray was performed and found that the whole cu cannula was still sitting in the location where the procedure was performed.A neurosurgeon was called in to perform a surgical procedure in which the cannula wire was removed.The patient has recovered and is doing well post-operatively.
Event or Problem Description
It was reported that during the radiofrequency ablation procedure the physician removed the electrode from the patient and saw a piece of metal wire remained in the patients body.An x-ray was performed and found that the whole cu cannula was still sitting in the location where the procedure was performed.A neurosurgeon was called in to perform a surgical procedure in which the cannula wire was removed.The patient has recovered and is doing well post-operatively.
Additional Manufacturer Narrative
Correction to initial mdr in fields d4 model number, catalog number, expiration date, and unique identifier udi.Device technical analysis: visual inspection of the returned cu injection electrode revealed that the needle of the injection electrode had broken off from the hub and event of physician finding a wire in the patients body after removing the electrode during the radiofrequency ablation procedure was confirmed.The separated needle was likely due to unintended excessive external mechanical force.Investigation conclusion: based on the provided information, the probable cause is unintended use error caused or contributed to event.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10062475
• Report Number: 3006630150-2020-02076
• Device Sequence Number: 11665344
• Product Code: GXI
• UDI-Device Identifier: 00813250016314
• UDI-Public: 00813250016314
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K082012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2020

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: 04/04/2022
• Device Model Number: CU-10520U
• Device Catalogue Number: CU-10520U
• Device Lot Number: P349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 07/14/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 07/01/2020; 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention