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	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer ¿the product returned has 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; there is dried body fluid along the edge of the ring.There is a cut in the distal insulation approximately 8cm from the distal tip.The catheter was placed on the curve template and the device passed the right curve test however the device has a kink at the distal section at approximately 13mm from the tip.The device did not pass the left curve test; the tip did not reach the shaded area of the template.The distal section was dissected.There is a small amount of body fluid under the r1 ring 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.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 analysis completed on 21 april 2017.It was reported it became stiff and the steering mechanism stopped working.Atrial fibrillation ablation was attempted using a intellatip mifi¿ xp temperature ablation catheter.During the procedure the device became stiff and the steering mechanism stopped working, so it was replaced with a new device and the procedure was completed.No patient complications were reported and the patients status was fine.However; returned device analysis revealed the seal of ring 1 is compromised and a cut in the distal insulation.

• 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: 6515573
• Report Number: 2134265-2017-04427
• Device Sequence Number: 1458363
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: (01)08714729848028(17)20191013(10)0019838108
• 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): 04/21/2017

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: 10/13/2019
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 0019838108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1