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

Model Number	M004R4500THK20
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was received for analysis after decontamination; the upn and lot number match those provided by the customer.The steering knob and the tension control knob functioned properly on both lock and unlock positions.There is a bend in the distal end approximately 23mm from the distal tip in the neutral position.There is body fluid under ring 2 and in the interior of the sheath, and it is likely the ring seal was compromised during the procedure due to the bend in the distal tip.An lcr test was performed and the sensor was found to have an open circuit in the right curve position and low resistance measurement results in the neutral and left curve positions; the sensor is almost half the resistance expected in the neutral position.X-rays revealed a break in the sensor wire between ring 2 and ring 3.The distal section was dissected, and the open in the sensor wire was visually confirmed.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 or Problem Description
Reportable based on analysis completed april 21, 2017.It was reported that during an ablation procedure, an arrhythmia was induced and the physician introduced the intellanav¿ xp ablation catheter to map; however, the catheter could not be seen on the rhythmia mapping system.The procedure was completed with another of the same device.There were no patient complications.However, returned product analysis revealed body fluid under ring 2 and in the interior of the sheath, and that it is likely the ring seal was compromised during the procedure due to a bend in the distal tip.

• Brand Name: INTELLANAV¿ 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: 6571823
• Report Number: 2134265-2017-04736
• Device Sequence Number: 13488469
• Product Code: OAD
• UDI-Device Identifier: 08714729885757
• UDI-Public: (01)08714729885757(17)20190706(10)0019430849
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/21/2017

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: 07/06/2019
• Device Model Number: M004R4500THK20
• Device Catalogue Number: R4500THK2
• Device Lot Number: 0019430849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR