MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced a cardiac tamponade.During an ablation procedure to treat an arrhythmia, the physician used 8.5f non-boston scientific sheath and an intellamap orion catheter for positioning and ablation.During mapping, when the orion catheter reached the target position at right ventricular outflow tract (rvot), the patient said her chest felt uncomfortable.X ray showed cardiac tamponade.Blood pressure decreased from 120/80mmhg to 90/60mmhg.Pericardiocentesis was performed and 260ml of non-clotting blood was drawn.The blood pressure recovered to 120/70mmhg.Rescue was successful and physician decided to stop surgery.The patient's consciousness was clear during surgery and rescue.The patient was sent to intensive care unit for observation.It was suspected that the event was related to the "too deep" position of the sheath, but it was hard to judge if the event was related to the orion.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 04:40 pm ct.The report number is being corrected from: 2124215-2018-62258 to: 2134265-2018-61418.

Event Description

This supplemental report is being filed because the product was returned and analyzed.

Event Description

It was reported that the patient experienced a cardiac tamponade.During an ablation procedure to treat an arrhythmia, the physician used 8.5f non-boston scientific sheath and an intellamap orion catheter for positioning and ablation.During mapping, when the orion catheter reached the target position at right ventricular outflow tract (rvot), the patient said her chest felt uncomfortable.X ray showed cardiac tamponade.Blood pressure decreased from 120/80mmhg to 90/60mmhg.Pericardiocentesis was performed and 260ml of non-clotting blood was drawn.The blood pressure recovered to 120/70mmhg.Rescue was successful and physician decided to stop surgery.The patient's consciousness was clear during surgery and rescue.The patient was sent to intensive care unit for observation.It was suspected that the event was related to the "too deep" position of the sheath, but it was hard to judge if the event was related to the orion.The device was returned for analysis.Visual inspection showed no visible abnormalities.The electrical test was performed and the device passed the test.The device passed all relevant testing/inspection.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/12/2018 02:58 pm ct.The report number is being corrected from: 2134265-2018-63947 to: 2134265-2018-61418.This report is follow-up # 1.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 7920038
• MDR Text Key: 122147922
• Report Number: 2134265-2018-61418
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2019
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Device Lot Number: 0021762353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 12/04/2018
• Supplement Dates FDA Received: 01/22/2019; 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: ABBOTT SL1, 8.5F; SHEATH: ABBOTT SL1, 8.5F
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR