MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER PRIME¿ XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004EPTP4500THN40

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the device has a kink at the distal section approximately at 1.2 cm from the distal tip while in the neutral position and broken adhesive was observed in ring #1.Functional inspection revealed that the steering knob and the tension control knob functioned properly on both lock and unlock positions and no abnormal resistance was felt when actuating the steering mechanism.X-ray inspection revealed a bent center support under the same location of the kink at the distal section.A steering wire partially detached from the center support due to broken solder joint was also observed.Distal end was dissected and bent center support was confirmed between ring 1 and ring 2 and a damage in the kevlar wrap.The distal tip was dissected, the steering wire was partially separated from the center support due to a broken solder joint.Dried body fluid was found within the distal end and the kevlar wrap was found retracted.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 Description

Reportable based on device analysis completed on 07-june-2018.It was reported that the catheter tip were kinked.A 7-110-2.5-8-8 n4 blazer prime¿ xp ablation catheter was used for a typical atrial flutter ablation procedure.A non-bsc sheath was used to pass and support the catheter in the low right atrium region to perform a cavo-tricuspid isthmus (cti) line.Then, the catheter tip was noted to be kinked between the second and third electrode after being used for short period in the cti.The catheter was withdrawn and the procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed a body fluid ingress within the distal end.

• Brand Name: BLAZER PRIME¿ XP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7616005
• MDR Text Key: 111560634
• Report Number: 2134265-2018-05691
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: M004EPTP4500THN40
• Device Catalogue Number: EPTP4500THN4
• Device Lot Number: 21791160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1