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	M004PM45000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received for analysis.The device was returned in the left curve position.There was dried body fluid on the distal end and the tip had some minor scratches.The seals of all three rings had been compromised.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against curve template.The right curve test passed.The left curve failed to reach the specified template area; the tip did not curve to the left.X-ray showed that a steering wire had retracted to between ring 2 and ring 3.X-rays showed no evidence of guide coil collapse.The distal section was dissected.There was a significant amount of body fluid under r1 and r2 rings and in the interior of the sheath.The kevlar wrap was displaced.One of the steering wires was detached; there was evidence of solder on the center support.The detached steering wire had retracted under the kevlar wrap.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 or Problem Description
Reportable based on device analysis completed on 22dec2017.It was reported that the steering mechanism broke.During an ablation procedure to treat atrial fibrillation with an intellatip mifi xp ablation catheter, the physician suspected a steering wire break.The procedure was completed with another of the same device and there were no patient complications.Device analysis revealed that the seals of all three rings had been compromised.

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7200255
• Report Number: 2134265-2017-13260
• Device Sequence Number: 13707195
• Product Code: OAD
• UDI-Device Identifier: 08714729848011
• UDI-Public: 08714729848011
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2020
• Device Model Number: M004PM45000
• Device Catalogue Number: PM4500
• Device Lot Number: 20906446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1