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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The device was returned in the right curve position.There was a kink located approximately 13mm from the distal tip between the ring 1 and ring 2.The seal on ring 1 was compromised.There were two tears in the proximal seal on the inside of the kink.The portion of the seal between the tears was still attached to the device.The seal on ring 2 was compromised; a portion of the seal was lifted off the insulation but is intact.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against curve template.The left curve failed to reach the specified template area.The right curve test passed, but had an irregular shape due to a kink.X-ray showed a bent center support.There was evidence of guide coil collapse in the handle.The distal section was dissected.There was a small amount of body fluid in the interior of the sheath.The kevlar wrap was displaced and the center support was bent.The solder connection on one of the steering wires was cracked.The insulation on one of the thermistor wires was scraped off where it was pressed against the edge of the center support.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 11jan2018.It was reported that the catheter would no longer deflect or steer.During an ablation procedure to treat right atrial flutter in the right atrium with an intellatip mifi xp ablation catheter, the catheter deflection stopped working mid-case and would no longer steer.The procedure was completed with another of the same device without incident or issue to patient.Device analysis revealed the seal on ring 1 and ring 2 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): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7216555
• Report Number: 2134265-2018-00404
• Device Sequence Number: 1027999
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: 08714729848028
• 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): 01/11/2018

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: 07/04/2020
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 20848884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR