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

Model Number M00420SL21020

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis.The returned device matches the upn and lot number provided by the customer.There is a cut in the insulation approximately 15.5cm from the distal tip which is proximal to ring 19.The insulation cut is parallel with the rings and extents halfway across the diameter of the shaft.It appears that the cut is shallow and does not extend to the wires inside the shaft.There is a bend in the distal end at approximately 8.5cm from the tip which is between rings 11 and 12.There is an excessive amount of dried blood and body fluid on all the rings and shaft and especially on the tip.Continuity checks revealed no electrical shorts as checked manually using a multi-meter and test cable.Ring 13 and ring 19 were found to be open.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/fixture.The left curve failed to reach the specified template area.The right curve test passed.X-ray showed no obvious anomalies in handle/flex board or in the proximity of ring 13 or ring 19.X-rays showed evidence of guide coil collapse in the proximal shaft.The handle was opened and no visual abnormalities were noted on the flex board and electrode solder connections.Continuity between the flex board and the handle connector was present for r13 and r19 wires.A section of the proximal shaft insulation was removed and the collapsed guide coil was visually confirmed.There was continuity between this point in the proximal shaft and the handle connector for r13 and r19 wires.Inspection of the ring 13 noted that the ring is slightly flattened.Inspection after dissection of the distal end showed broken wires near the welds to both ring 13 and ring 19 electrodes.A segment of the wire was still welded to the both electrodes.There is dried body fluid under both ring 13 and 19 and in the interior of the shaft.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based on device analysis completed on 25-aug-2017.It was reported that the signals were compromised.A 7f blazer¿ dx-20 catheter was selected for use.During the procedure, it was noted that some of the signals were compromised.The catheter was removed from the body and it was noted that the distal end had "a strange torqued look to it".The procedure was completed successfully.No patient complications reported.However, device analysis revealed a cut in the insulation approximately 15.5cm from the distal tip which is proximal to ring 19.

• 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: 6842702
• MDR Text Key: 85003442
• Report Number: 2134265-2017-09054
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2020
• Device Model Number: M00420SL21020
• Device Catalogue Number: 20SL2102
• Device Lot Number: 20174129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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