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

Model Number	M00420SL2520
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned device revealed that there was a kink and a perforation of the shaft at the distal section approximately at 6.5 cm from the distal tip while in the neutral position.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.The electrical test was performed in the right, neutral and left curve configurations and the device was found out of specification since opens were found in four different rings (r14, r17, r18 & r19).No shorts were found.Broken and rolled center support and a bent steering wire was observed under x-ray in the same location of the kink at the distal section.Moreover, a circumferential cut of the shaft was observed within the strain relief.During dissection a knot was observed in the electrical wires in the distal shaft that produces broken wires resulting in the electrical opens.Dissection confirmed broken/rolled center support and bent steering wire between ring 14 and ring 15, this also have caused a damaged in the kevlar wrap.The strain relief was removed and was confirmed the circumferential cut of the shaft.Kevlar was removed from the distal end of the guide coil confirming the four solder points located in the coil.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 or Problem Description
Reportable based on device analysis completed on 06-june-2018.It was reported that signal issues occurred.During the procedure, it was noted that the blazer¿ dx-20 catheter was not functioning.It was plugged in but no signals were noted.Then, another cable was used but the problem was not resolved.The procedure was completed with another of the same device.No patient complications reported.However, device analysis revealed that there was a perforation of the shaft at the distal section approximately at 6.5 cm from the distal tip.

• Brand Name: BLAZER¿ DX-20 CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7641475
• Report Number: 2134265-2018-05646
• Device Sequence Number: 2512737
• Product Code: DRF
• UDI-Device Identifier: 08714729780502
• UDI-Public: 08714729780502
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K081576
• 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): 06/06/2018

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: 09/07/2020
• Device Model Number: M00420SL2520
• Device Catalogue Number: 20SL252
• Device Lot Number: 0021110124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1