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 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(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 returned device has the distal end curving to the right in the neutral position.There is a kink in the device approximately 13mm from the distal tip in the neutral position; the kink is between r1 and r2.The seal of ring 1 is compromised and there is dried body fluid along the edges of the ring.The catheter was placed on the curve template and the device failed both right and left curves tests; the tip does not reach the shaded area of the template.X-rays revealed that the center support is bent.There is no evidence of collapsed coil.The distal section was dissected.There is body fluid under r1 and r2 rings and in the interior of the sheath.The kevlar wrap is displaced and the center support is bent.One of the steering wires is detached; there is evidence of solder on both the center support and the detached steering wire.It is likely the seal on ring 1 being compromised was an induced failure during the procedure due to the bent center support/kink in the distal section.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).

Event Description

Reportable based on analysis completed (b)(6) 2017.It was reported that during an atrial flutter procedure an intellatip mifi¿ xp temperature ablation catheter was advanced into the right atrium.During the procedure the steering control broke and the catheter tip was bent.It was noted the catheter had not been pre-bent prior to insertion, was not kinked, and had not been over torqued.The procedure was completed with another of the same device.There were no patient complications and the patient was in stable condition.However, returned device analysis revealed the seal on ring 1 was compromised and there was body fluid along the edge of the ring.

• 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: 6456132
• MDR Text Key: 71594929
• Report Number: 2134265-2017-03135
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 19689631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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