MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004EPMR9620K20

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: visual inspection showed there is a crease located approximately 109.5cm from the distal tip which is just distal of the handle strain relief.The device was returned with a piece of blue tape wrapped around the handle.The tape, which is approximately 19cm long, was unwrapped from the handle.There was a pieces of clear plastic affixed to the tap.There were no blemishes or abnormalities under the tape on the handle.The device was connected to the metriq pump and all 6 irrigation ports appear to have normal flow/spray.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018.It was reported that not all holes are flushing during ablation.The intellanav mifi open-irrigated ablation catheter was selected for a atrial flutter ablation procedure.Physician used sterile tape to close the gap at the connector between the non sterile umbilical cable in a overcoat and the sterile handle of the catheter.Irrigation flushed the holes not as strong as normal.Physician told the fcs that not all holes are flushed during ablation (only 4 of 6).Catheter was used for 20 ablation points.The procedure was completed with a non-bsc device.No patient complication were reported.However; returned device analysis revealed foreign matter.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 7323780
• MDR Text Key: 101982092
• Report Number: 2134265-2018-01700
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P150005
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2019
• Device Model Number: M004EPMR9620K20
• Device Catalogue Number: EPMR9620K2
• Device Lot Number: 21176225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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