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

Model Number	36723
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Burn(s) (1757); Fever (1858)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported insufficient roll-off and pad burns occurred.The patient had a 5cm tumor at the right upper renal pole.Embolization of the tumor-feeding vessels using particles was performed on the previous day.On (b)(6) 2019, the patient was undergoing a radio frequency ablation (rfa) of the right kidney.The positioning of the patient was lateral oblique left, so the patient was lying on her side.Two grounding pads were placed on the backside of each thigh (four total).The first ablation with the 5cm needle went exactly according to algorithm.After 56 minutes, roll off was achieved at 200 watts.The 2nd roll off was achieved after 9 minutes at 200 watts.For the second ablation, the needle was drawn back by 3cm.After a long time, roll-off was not achieved.After 80 minutes, the procedure had to be cancelled since the patient developed a fever of 40 degrees celsius.When turning the patient around, it was noticed the patient had 2nd degree pad burns along the edges of the pads.The patient did not have a urinary catheter but only wore a disposable diaper so moisture may have gotten underneath the electrodes since the electrodes were fixed on the back of the thigh.The physician believed this may have compromised the function of the electrodes.During the procedure, the patient experienced renal failure.A coagulum was found in the ureter; a ureteral stent was placed.The patient was placed in the intensive care unit.The patient was not excreting.The patient developed sepsis and still had a fever as of (b)(6) 2019.The physician stated that it is unknown if the renal failure and sepsis was related to the procedure.On (b)(6) 2019, it was reported the patient was doing much better.The kidney was beginning to work again.It was noted the patient would be transferred to the regular ward within the next days.On (b)(6) 2019, it was reported the patient had transferred to the regular ward on (b)(6) 2019.The patients kidney values and circulation had stabilized.
Event or Problem Description
It was reported insufficient roll-off and pad burns occurred.The patient had a 5cm tumor at the right upper renal pole.Embolization of the tumor-feeding vessels using particles was performed on the previous day.On (b)(6) 2019, the patient was undergoing a radio frequency ablation (rfa) of the right kidney.The positioning of the patient was lateral oblique left, so the patient was lying on her side.Two grounding pads were placed on the backside of each thigh (four total).The first ablation with the 5cm needle went exactly according to algorithm.After 56 minutes, roll off was achieved at 200 watts.The 2nd roll off was achieved after 9 minutes at 200 watts.For the second ablation, the needle was drawn back by 3cm.After a long time, roll-off was not achieved.After 80 minutes, the procedure had to be cancelled since the patient developed a fever of 40 degrees celsius.When turning the patient around, it was noticed the patient had 2nd degree pad burns along the edges of the pads.The patient did not have a urinary catheter but only wore a disposable diaper so moisture may have gotten underneath the electrodes since the electrodes were fixed on the back of the thigh.The physician believed this may have compromised the function of the electrodes.During the procedure, the patient experienced renal failure.A coagulum was found in the ureter; a ureteral stent was placed.The patient was placed in the intensive care unit.The patient was not excreting.The patient developed sepsis and still had a fever as of (b)(6) 2019.The physician stated that it is unknown if the renal failure and sepsis was related to the procedure.On (b)(6) 2019, it was reported the patient was doing much better.The kidney was beginning to work again.It was noted the patient would be transferred to the regular ward within the next days.On (b)(6) 2019, it was reported the patient had transferred to the regular ward on (b)(6) 2019.The patients kidney values and circulation had stabilized.It was further reported that the patient is doing better and the burns are healing.
Additional Manufacturer Narrative
Device evaluated by mfr: one leveen needle electrode was returned for analysis.The cable was not returned for analysis.Residues in handle indicate use and handling of the device.No visual damages defects were observed on the electrode.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.Excessive residues were found in the tines.An electrical evaluation was performed and was within specification.Resistance test with the electrode was performed and was within specification.
Event or Problem Description
It was reported insufficient roll-off and pad burns occurred.The patient had a 5cm tumor at the right upper renal pole.Embolization of the tumor-feeding vessels using particles was performed on the previous day.On (b)(6) 2019, the patient was undergoing a radio frequency ablation (rfa) of the right kidney.The positioning of the patient was lateral oblique left, so the patient was lying on her side.Two grounding pads were placed on the backside of each thigh (four total).The first ablation with the 5cm needle went exactly according to algorithm.After 56 minutes, roll off was achieved at 200 watts.The 2nd roll off was achieved after 9 minutes at 200 watts.For the second ablation, the needle was drawn back by 3cm.After a long time, roll-off was not achieved.After 80 minutes, the procedure had to be cancelled since the patient developed a fever of 40 degrees celsius.When turning the patient around, it was noticed the patient had 2nd degree pad burns along the edges of the pads.The patient did not have a urinary catheter but only wore a disposable diaper so moisture may have gotten underneath the electrodes since the electrodes were fixed on the back of the thigh.The physician believed this may have compromised the function of the electrodes.During the procedure, the patient experienced renal failure.A coagulum was found in the ureter; a ureteral stent was placed.The patient was placed in the intensive care unit.The patient was not excreting.The patient developed sepsis and still had a fever as of (b)(6) 2019.The physician stated that it is unknown if the renal failure and sepsis was related to the procedure.On (b)(6) 2019, it was reported the patient was doing much better.The kidney was beginning to work again.It was noted the patient would be transferred to the regular ward within the next days.On (b)(6) 2019, it was reported the patient had transferred to the regular ward on (b)(6) 2019.The patients kidney values and circulation had stabilized.It was further reported that the patient is doing better and the burns are healing.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8605381
• Report Number: 2134265-2019-04880
• Device Sequence Number: 16737191
• Product Code: GEI
• UDI-Device Identifier: 08714729454915
• UDI-Public: 08714729454915
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: 36723
• Device Catalogue Number: 36723
• Device Lot Number: 0022269179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 06/21/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/05/2019; 07/12/2019
• 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: Required Intervention
• Patient Age: 65 YR