MAUDE Adverse Event Report: ARDEN HILLS, MN INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PM4500K20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr:the device was returned in the left curve 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 ring seals of r1 and r2 appear to be compromised as both have evidence of body fluid under them.The ring seal of r3 is intact and there was no body fluid noted.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 the right curve test; the tip does not reach the shaded area of the template.The distal section was dissected.There is a small amount of 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 into an ¿s¿ shape and is fractured at the top of the ¿s¿.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 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 or Problem Description
Reportable based on device analysis completed november 22, 2016.It was reported that the steering wire broke.An intellatip mifi¿ xp temperature ablation catheter was selected and advanced for use.During the procedure, the catheter was no longer able to be deflected in a bidirectional manner.The catheter was exchanged and the procedure completed with another of the same device.No patient complications were reported and the patient's status is fine.However, returned device analysis revealed the ring seals were compromised.

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• MDR Report Key: 6173650
• Report Number: 2134265-2016-11436
• Device Sequence Number: 16339653
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: (01)08714729848028(17)20190526(10)19286452
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/22/2016

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: 05/26/2019
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 19286452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 12/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1