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	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Ring 1 seal is compromised.Body fluid is present on the seal of the tip.There is a scratch on the tip.The catheter was placed on the curve template and the device passed the right curve test; the tip reached the shaded area of the template.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 does not curve to the left.X-rays revealed that the center support is bent between ring 1 and ring 2 and that one of the steering wires is not attached.There was one area under the strain relief in which evidence of collapsed guide coil was noted.The distal section was dissected.No body fluid was noted 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 detached steering wire had retracted under the kevlar wrap.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 (b)(6) 2017.It was reported that the catheter steering mechanism broke.Right atrial fibrillation ablation was attempted using a intellatip mifi¿ xp temperature ablation catheter.During ablation the catheter steering mechanism broke, so it was replaced with a new device and the procedure was completed.No patient complications were reported.However; returned device analysis revealed the seal of all ring 1 is compromised.

• 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: 6653027
• Report Number: 2134265-2017-06529
• Device Sequence Number: 13835569
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: (01)08714729848028(17)20190526(10)19286452
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: 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: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2134265
• Patient Sequence Number: 1