MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER DX-20; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86700
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.The customer also provided a picture where it was possible to observe the catheter of a blazer device kinked and tied with a fiber that maintain the tip of the device bent.Visual inspection of the device showed that it was returned with a unknown introducer and the device has a kink 2cm from the distal tip.The introducer was attached to the catheter shaft but it did not affect the catheter.Additionally, the distal tip looks like if it was tied with something similar to a gauze or tissue and it causes the kink on the distal tip.The steering knob and the tension control knob functioned properly on both lock and unlock positions.There was no abnormal resistance was felt when actuating the steering mechanism.Both curves failed to reach the specified area of the template due to the catheter tip did not fall within the green region of the template, due to the kink on the distal tip.The device failed the dimensional test.The device was inspected using an optical microscope and some pictures of the distal tip were captured.The device met all the manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, however, there is no control of how the unit was handled at the field.
Event or Problem Description
It was reported that during an ablation procedure to treat paroxysmal supraventricular tachycardia (psvt), in the process of approaching the blazer dx catheter to the coronary sinus (cs) ostium, the catheter "was not curved." the catheter didn't move at the tricuspid valve (tv) muscle due to it being unable to curve for cs approach.The curve was jammed or unable to be straightened.The catheter was "stuck" at the muscle and would not move.The physician tried many times to extract the device, but was unable to.Therefore, the physician needed to use a trio sheath connector to extract the blazer dx catheter from the muscle.The procedure was then completed with another device.The device was returned to boston scientific for analysis.

• Brand Name: BLAZER DX-20
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11741321
• Report Number: 2134265-2021-05429
• Device Sequence Number: 4167591
• Product Code: DRF
• UDI-Device Identifier: 08714729780526
• UDI-Public: 08714729780526
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0026139453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR