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 M004PM4500N40

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - the device has a kink at 14mm from the tip while in the neutral position (between ring 1 and 2).In addition the ring #1 has broken adhesive and fluids under it.In addition, the shaft is ripped at 13mm and 15mm from the tip.X ray image analysis revealed that the center support is broken.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 following a radio frequency cardiac ablation (rfca) procedure, the inner was exposed.Following successful ablation with the intellatip mifi¿ xp temperature ablation catheter the shaft near the tip was kinked and object like wire was exposed, no patient complications were reported and the patient status is good.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the catheter was used with a non-bsc 8f sheath.The kink was noted when deflecting the large shape curve of the asymmetrical curve, the curve tension control was sent to the plus (maximum) position.The kink/bend was noted between he 2nd and 3rd electrode.The exposed wire was noted by the distributer following conclusion of the procedure.

• 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: 5187674
• MDR Text Key: 29813595
• Report Number: 2134265-2015-07263
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

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: 12/31/2017
• Device Model Number: M004PM4500N40
• Device Catalogue Number: PM4500N4
• Device Lot Number: 0017499145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 91104079-FA
• Patient Sequence Number: 1