MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004PM4500K20

Device Problems Bent (1059); Break (1069); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that prior to a procedure a break occurred.As the intellatip mifi¿ xp temperature ablation catheter was removed from the packaging the catheter was bent and ¿and they think they broke it".The catheter was tested and it wasn¿t working right.The catheter was never inserted into the patient.The procedure was completed with another intellatip mifi¿ xp temperature ablation catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer - unit returned with its original box labeled batch 17925494, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The device has a kink at 14mm from the tip while in the neutral position (between ring 1 and 2).X-ray analysis revealed that the center support is kinked.The device was dissected, finding evidence of fluids in the kevlar.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that prior to a procedure a break occurred.As the intellatip mifi¿ xp temperature ablation catheter was removed from the packaging the catheter was bent and ¿and they think they broke it¿.The catheter was tested and it wasn¿t working right.The catheter was never inserted into the patient.The procedure was completed with another intellatip mifi¿ xp temperature ablation catheter.No patient complications were reported.

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5443680
• MDR Text Key: 39020755
• Report Number: 2134265-2016-01441
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2018
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 17925494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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