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

Model Number M004EPTR9620K20

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that there are two kinks located approximately 5cm and 7.3cm from the distal tip.A section of the ring 1 seal is missing from the proximal side of the electrode.It appears the section of the seal had been torn away; the edges are clean.However, there is enough adhesive remaining on the electrode and insulation shaft to complete the electrode edge seal; the seal itself is not compromised.Dimensional inspection was done.The tip motion was evaluated against curve template.Both right and left curve tests failed.X-ray showed the center support is bent in two places.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 analysis completed on 03-may-2018.It was reported that the catheter was kinked.A 7/110/2.5/quad k2 ous intellanav oi was selected for use.During procedure, it was noted that the catheter was kinked and did not perform well.After changing to a new catheter it was possible to maneuver in the region of interest.The procedure was completed with another with same device.No patient complications were reported.However, returned device analysis revealed that a missing section of adhesive.

• 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: 7534668
• MDR Text Key: 108988479
• Report Number: 2134265-2018-04606
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: M004EPTR9620K20
• Device Catalogue Number: EPTR9620K2
• Device Lot Number: 21239844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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