MAUDE Adverse Event Report: ANGIODYNAMICS UNIBLATE ELECTRODE; ELECTROSURGICAL PROBE

Catalog Number	H7877001035981
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference # (b)(4).
Event or Problem Description
As reported: during an rfa procedure using an uniblate fra probe, it was reported the trocar detached from the probe.The procedure was aborted due to this event.As the treatment was not completed, the patient was sedated unnecessarily.This is considered an adverse patient effect due to patient safety risk.The reported defective device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a uniblate 10cm probe.A visual review of the device noted that the insulation sleeve was loose on the trocar.The reported complaint description is confirmed.A visual review of the device noted that the polyimide sheath was loose on the trocar.Device has been used and residue all inside the device.Inspected the bonding site of the insulation and puck and found adequate glue in the area.The insulation would not move when reattached to the puck when attempting deploy.Cleaned the trocar and inside the insulation and then the insulation would retract properly.Based on the investigation it appears bio material had bonded the insulation and the trocar.If the device was attempted to be deployed after this bond was created, it could break the bond of the insulation and the inner puck.Although the complaint is confirmed a root cause for the event cannot be determined, however it does not appear to be manufacturing related.A device history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use, which is supplied to the user with this catalog number contains the following statements: "do not attach anything (i.E., clamps, etc.) to the device.This may damage the insulation, which could contribute to patient injury.Do not bend or kink the trocar.This may cause damage and result in a non-functional device." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: UNIBLATE ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9192643
• Report Number: 1319211-2019-00137
• Device Sequence Number: 19773888
• Product Code: GEI
• UDI-Device Identifier: H7877001035981
• UDI-Public: H7877001035981
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 10/10/2018
• Device Catalogue Number: H7877001035981
• Device Lot Number: 5379626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: Other