MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87141

Device Problems Low impedance (2285); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the catheter showed a kink in the distal section approximately 1.3 cm from the catheter tip while in the neutral position.Inspection of the steering knob and tension control knob revealed proper function on both lock and unlock positions and no abnormal resistance was felt when actuating the steering mechanism.A dimensional inspection was performed during which the catheter curves were evaluated against a curve test template.Both the right and left curves reached the specified areas of the template, passing the test.During electrical testing the catheter was found to be out of specification.There were no open circuits, however, there was shorting between the tip and ground.Radiofrequency (rf) energy delivery was verified by using a maestro 4000 generator and the device was found to be within specifications.X-ray demonstrated a bent center support in the same location as the kink in the distal section and a partially detached steering wire from the center support due to a broken solder joint.The catheter distal end was dissected which confirmed the bent center support and detached steering wire.The kevlar wrap was observed to be retracted and it measured out of specification.Dried body fluid was found within the distal end.The insulation on the thermistor wire was peeled in the location of the bent center support.

Event Description

This event is reportable upon analysis completed 19 june 2019.It was reported that the catheter was deformed.The patient underwent ablation for isthmus flutter.During the procedure the physician noticed that the impedance was lower and upon withdrawal of the blazer prime xp catheter it was observed to be deformed but still intact.The catheter was used according to standard and it was noted that no extra force had been applied and no resistance was felt during insertion.The procedure was completed with another blazer prime xp catheter and there were no patient complications.Returned device analysis revealed a bent center support which led to fluid ingress within the distal end through a broken ring adhesive.

• Brand Name: BLAZER PRIME XP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8798525
• MDR Text Key: 151305805
• Report Number: 2134265-2019-08336
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: 87141
• Device Catalogue Number: 87141
• Device Lot Number: 0022770321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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