MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI

Model Number	87045
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination revealed that the distal end is bent into a partial right curve with steering knob in neutral position.Butt bond seal is cracked and dried body fluid found inside the butt bond.Dried body fluid also found surrounding the connector at the back of the handle.Dried body fluid on the handle, main shaft, and distal end.Dried saline found on the distal end and inside several irrigation ports.Electrical continuity checks revealed no electrical shorts as checked manually using a multi-meter and breakout box.Tip is shorted to tc+, tc-, ring 3, sensor 1 & sensor 2.All electrodes, sensor and thermocouple resistances measured in spec and were typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.Abnormally high resistance was felt when actuating the steering mechanism.The device was plugged into a maestro generator 4000.The device was recognized by the generator.The distal end was opened.The entire distal cavity is full of dried blood.Next, the handle was opened.Dried body fluid was found throughout the interior cavity, on the pcb, and surrounding the rear connector solder joints.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Reportable based on device analysis completed april 22, 2019.It was reported that during an ablation procedure for premature ventricular contractions (pvc), the intellanav oi catheter was no longer sensed by the maestro 4000 generator.The maestro pod.Ablation box and applicable cables were all replaced, to no effect.A new intellanav oi catheter was then used which solved the issue.There were no patient complications.However, returned device analysis revealed body fluid ingress.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8615304
• Report Number: 2134265-2019-05356
• Device Sequence Number: 11281253
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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 Expiration Date: 10/30/2021
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0022872090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1