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 M004PM4790K20

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: unit received in a decontamination pouch, overall visual did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.There is a kink in the device approximately 14mm from the distal tip in the neutral position.The kink is between r1 and r2.The ring1 seal is split along the edge of the ring at the top of the kink¿s curve.There is dried body fluid along the sides of the ring.Ring 2 also has dried body fluid on the sides of the ring however the seals appear to be intact.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The catheter was placed on the curve template and the device failed both the right and left curves tests; the tip did not reach the shaded area on the template in either direction.Electrical test was performed and the device was found to be within specifications.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.The distal section was dissected.There is a large amount of body fluid in the interior of the sheath.Also, there is some body fluid under ring1 and ring2.The kevlar wrap is displaced and the center support is bent into a ¿v¿ shape.One of the steering wires is detached; there is evidence of solder on both the center support and the detached steering wire.The manufacturing batch record review confirms the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that no signal occurred.After positioning the intellatip mifi¿ xp temperature ablation catheter in the patient, the cable was connected; however the electric potential was not displayed.Changing the cable did not resolve the issue.The issue was resolved by exchanging the catheter to another of the same device.No patient complications were reported and the patient's status is stable.However, returned device analysis revealed the ring seal was compromised.

• 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: 6178249
• MDR Text Key: 62534411
• Report Number: 2134265-2016-12049
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729848059
• UDI-Public: (01)08714729848059(17)20190523(10)0019286449
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2019
• Device Model Number: M004PM4790K20
• Device Catalogue Number: PM4790K2
• Device Lot Number: 0019286449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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