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 Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - visual inspection revealed a kink in the main body tubing between rings 1 & 2.A small section of seal is missing from the proximal edge of ring 1.Body fluid ingress can be found through the void of the missing seal section.Body fluid ingress was also found through a narrow split in the seal at the proximal edge of ring 1, along the outside curve of the kink.Dried body fluid was found on the handle, main body tubing, and on the distal end.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 specified curve and both right and left curve tests failed.X-ray found a bent center support between rings 1 & 2.A steering wire has separated from the center support.The distal section was dissected.Dried body fluid was found throughout the dissected area.The kevlar wrap is displaced and the center support is bent.One of the steering wires has detached from the center support due to a broken solder joint.The other steering wire has a cracked solder joint, but has not separated from the center support.Visual inspection revealed a kink in the main body tubing between rings 1 & 2.A small section of seal is missing from the proximal edge of ring 1.Body fluid ingress can be found through the void of the missing seal section.Body fluid ingress was also found through a narrow split in the seal at the proximal edge of ring 1, along the outside curve of the kink.Dried body fluid was found on the handle, main body tubing, and on the distal end.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 specified curve and both right and left curve tests failed.X-ray found a bent center support between rings 1 & 2.A steering wire has separated from the center support.The distal section was dissected.Dried body fluid was found throughout the dissected area.The kevlar wrap is displaced and the center support is bent.One of the steering wires has detached from the center support due to a broken solder joint.The other steering wire has a cracked solder joint, but has not separated from the center support.The investigation conclusion is design specification as the device problem was traced back to the design specifications.Age at time of event: 18 years or older.(b)(4).

Event Description

Reportable based on analysis completed 19 dec 2017.It was reported that during the procedure the steering control was broken, the catheter tip was bent.The procedure was completed with another intellatip mifi¿ xp temperature ablation catheter.No patient complications were reported and the patients' condition is stable.However; returned device analysis revealed a small section of seal is missing from the proximal edge of ring 1.

• 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 Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7185573
• MDR Text Key: 97081457
• Report Number: 2134265-2017-13069
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 20234678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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