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 M004EPM4500K20

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis.Unit was received for analysis after decontamination (in appropriate packaging).There was a kink located approximately 13mm from the distal tip between ring 1 and ring 2.There was dried body fluid on the tip.Ring 1 seals were compromised; there was dried body fluid on the edges of the electrode.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 the curve template; both the right and left curve failed to reach the specified template area.X-ray showed a bent center support.There was also evidence of guide coil collapse near the strain relief.The insulation distal from the strain relief was removed and the collapsed guide coil was visually confirmed.The distal section was dissected.No evidence of body fluid in the interior of the sheath.The kevlar wrap was displaced and the center support was bent.Both steering wires were attached to the center support however one has a cracked solder joint.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 Description

Reportable based on device analysis completed on 04dec2017.It was reported that the tip of the catheter was kinked.An ablation procedure was performed with an intellatip mifi xp ablation catheter to treat right-sided atrial flutter.After the procedure, the tip of the catheter appeared bent.It was believed that manipulation during the procedure caused the bend/kink in the 8mm tip.Patient complications were not reported.Device analysis revealed that the ring 1 seals were compromised and there was dried body fluid on the edges of the electrode.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7126057
• MDR Text Key: 95530771
• Report Number: 2134265-2017-12445
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 20434444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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