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	M004PM4500K20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.There is a slight bend in the device approximately 13mm from the distal tip, between ring 1 and ring 2.An x-ray of the distal end revealed a bend in the center support.There was no evidence of a collapsed guide coil.The catheter was placed on the curve template and failed the left curve test; the tip does not curve to the left.The distal section was dissected.There is a small amount of body fluid under ring 1 and in the interior of the sheath.The kevlar wrap is displaced.One steering wire is detached and had retracted under the kevlar wrap; there is evidence of solder on both the center support and the detached steering wire.A device history record review was performed and no deviation was found.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 analysis completed may 23, 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 mechanism broke.The procedure was completed with another of the same device.There were no patient complications.However, returned device analysis revealed the seal on ring 1 was compromised and there were body fluids under the ring and in the interior of the sheath.

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6643025
• Report Number: 2134265-2017-05711
• Device Sequence Number: 1049643
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: (01)08714729848028(17)20200103(10)20118215
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/23/2017

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: 01/03/2020
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 20118215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1