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	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 80 years old.Device evaluated by mfr: the device was returned for analysis.The unit was received for analysis after decontamination (in appropriate packaging).The returned device matches the upn and lot number provided by the customer.The device was returned in a left curve position.There was dried body fluid on the handle and distal end.There was a kink located approximately 13cm from the distal tip between ring 1 and ring 2.Ring 1 seals werecompromised.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 the specified curve template.The right curve test passed, but had an irregular shape due to a kink.The left curve test failed; the tip did not curve to the left.X-rays showed a bent center support between ring 1 and ring 2 and evidence of guide coil collapse under the handle strain relief.The insulation distal from the strain relief was removed and the collapsed guide coil was visually confirmed.The distal section was dissected.There was body fluid under r1 ring and in the interior of the sheath.The kevlar wrap is displaced and the center support was bent.One of the steering wires was detached; there was evidence of solder on the center support.The detached steering wire had retracted under the kevlar wrap.The other steering wire was still attached to the center support however the solder joint was cracked.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion of the reported difficulty is a design constraint of the product.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 31oct2017.It was reported that the curve on the catheter broke.During an atrial flutter ablation procedure in the right atrium with an intellatip mifi xp ablation catheter, the curve on the ablation catheter broke.The procedure was completed with another of the same device and there were no patient complications.Device analysis revealed that the ring 1 (r1) seals were compromised and there was body fluid under r1 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: 7047985
• Report Number: 2134265-2017-11248
• Device Sequence Number: 16423861
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: 08714729848028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/31/2017

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: 03/01/2020
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 0020353779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1