MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER¿ DX-20 CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M00420SL21020

Device Problems Defective Component (2292); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.A visual inspection of the rings 18 and 19 were performed and revealed that the distal end were displaced.Rings 18 and ring 19 both have shifted toward the distal end; ring 18 has moved approximately 11mm and ring 19 approximately 13mm from their original position.Rings 16 and 17 also have shifted also shifted toward the distal end; both have shifted approximately 1mm from their original position.Functional inspection revealed that the steering knob and the tension control knob functioned properly on both lock and unlock positions.Electrical test was performed and the device was found rings r14 through ring 19 are open.Electrical test results revealed that there were resistance from connector to the ring wires and resistance from connector to tip wire.No shorts were found.An x-ray was taken and no abnormalities noted.Rings 16, 17, 18, and 19 were removed from the shaft.There are traces of adhesive on the sheath where each ring was originally placed in manufacturing; the adhesive does not cover the entire area of the ring area.Outer diameter measurement of the ring was taken and were within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 14feb2017.It was reported that signal noise and abnormal electrode spacing was noted.The 90% stenosed target lesion was located in the right atrium.A blazer¿ dx-20 catheter was selected for use.During the procedure, a noisy electrogram was noted.When the catheter was removed from the body, it was found that the 19th and 20th electrode had a strange gap, the spacing was shorter.No patient complications were reported and the patient's status was good.However, device analysis noted that the electrode rings were displaced.

• Brand Name: BLAZER¿ DX-20 CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 6384535
• MDR Text Key: 69270040
• Report Number: 2134265-2017-01646
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K081576
• 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: 02/14/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2019
• Device Model Number: M00420SL21020
• Device Catalogue Number: 20SL2102
• Device Lot Number: 19671966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• 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
• Patient Age: 53 YR