MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER® II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M0045031TH0
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the distal tip bends to the right in the neutral position and both the ring 2 and ring 3 seals are compromised; there is body fluid along the rings.No shorts were found during electrical test.X-rays did not reveal any abnormalities.Functional inspection noted that the steering knob and the tension control knob functioned properly on both lock and unlock positions.The catheter was placed on the curve template and the device did not pass the right and left curves tests; the tip did not reach the shaded area of the template.During rf ablation test, the device was connected to the maestro and a fault of d06 ¿ temperature out of range was displayed.A section of the proximal sheath near the strain relief was removed.There is continuity between the thermistor and ground wires to the connector.A portion of the proximal sheath near the torque hole was removed.There is continuity between the thermistor and ground wires to the connector.The distal end was dissected and the kevlar wrap is covering the solder connection between the center support and the steering wires but dried body fluid was found in the interior of the sheath.A twist in the thermistor wire was noted at approximately 30 cm from the distal tip.X-rays and microscopic inspection found a break in one of the thermistor wires approximately at 31 mm from the distal tip which is 1 mm proximal from the twist.The kevlar wrap was removed and revealed that the center support is bent approximately 2.6 cm from the distal tip.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 or Problem Description
Reportable based on device analysis completed on 05-apr-2017.It was reported that no signal on the recording system occurred and the steering mechanism was broken.A 7fr/4 mm blazer® ii htd was selected for use.During procedure when the physician used the device for mapping, it was noticed that the catheter's signal was not visible on the recording system.Furthermore, the catheter cable was replaced; however, the same issue occurred.The catheter was then removed and replaced with another of the same catheter and the signal was visible again on the recording system.No patient complications were reported.However, device analysis revealed that the ring 2 and ring 3 seals were compromised with body fluids.

• Brand Name: BLAZER® II HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6499650
• Report Number: 2134265-2017-03852
• Device Sequence Number: 1201574
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: (01)08714729172048(17)20190629(10)19407821
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2019
• Device Model Number: M0045031TH0
• Device Catalogue Number: 5031TH
• Device Lot Number: 19407821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR