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

Model Number M004EPTR9620K20

Device Problems Fluid/Blood Leak (1250); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device matches the upn and lot number provided by the customer visual inspection showed that there is a kink located approximately 15cm from the distal tip proximal to ring 3.There is dried body fluid and saline in the irrigation ports in the tip; the ring seals are intact.Dried body fluid is on the handle and along the left seam of the handle, along the hole plug, on both sides of the distal end of the handle, and around the strain relief.The seams of the handle appear to be intact.The butt bond seal is compromised.There is body fluid present along the seal.Continuity checks revealed no electrical shorts as checked manually using a multi-meter and breakout box.Functional testing showed the steering knob and the tension control knob functioned properly on both lock and unlock positions.Temperature testing showed that the catheter met expected values.Device was dissected and dried blood is throughout the entire length of the handle interior.There is also a large amount of the dried body fluid throughout the interior of the shaft.X-rays of the sensor revealed that one of the connecting wires between the sensor wire and the sensor body is fractured.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.The intellanav oi was selected for redo atrial fibrillation (af) ablation.The catheter fine at start of use.Temperature reading was 20 degrees in body (should read 37 degrees) and loss magnetic tracking occurred.Upon catheter inspection it was noticed that blood leaking from handle and a change in polymers on distal end of shaft was observed.The procedure was completed with another catheter and cable.No patient complications were reported.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: 7107803
• MDR Text Key: 94975913
• Report Number: 2134265-2017-11759
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: M004EPTR9620K20
• Device Catalogue Number: EPTR9620K2
• Device Lot Number: 20702757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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