MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV OI

Model Number M004EPTR96200

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned device matches the upn and lot number provided by the customer.Visual inspection reveled the butt bond seal is compromised and there is dried body fluid under the seal.There is dried saline/body fluid on the tip and rings.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The distal section was dissected to expose the magnetic sensor and it was noted that there is abundant dried blood in the interior of the sheath.X-rays showed no obvious anomalies.Further dissection determined that the open was in sensor wire 2 and was close to the sensor body.But due to the delicate nature of the sensor transition wires from the sensor wire to the sensor body, the area was damaged during dissection and the exact location of the wire break was not determined.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).

Event Description

Reportable based on device analysis completed on 13nov2017.A intellanav oi was selected for a cavo-tricuspid isthmus line(cti) line ablation on (b)(6) 2017.However during the cti line ablation the intellanav started flashing and a lot of artifact noise appeared on bipoles.The physician was unable to visualize catheter after two ablation lesions on cti.The procedure was completed using a different device.However, ; returned device analysis revealed a butt bond failure.

• Brand Name: INTELLANAV OI
• Type of Device: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7107681
• MDR Text Key: 94538673
• Report Number: 2134265-2017-11760
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: M004EPTR96200
• Device Catalogue Number: EPTR9620
• Device Lot Number: 20713699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1