MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EP-XT STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86718
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
The ep-xt steerable diagnostic catheter was selected for use during the procedure.It was reported that catheter entrapment occurred requiring gentle traction, there was a distal internal fracture, leading to 90-degree angulation and entrapment inside the body.The cardiologist managed to get the catheter free, a new catheter was used.D,f 3.5-mm mapping and ablation catheter was introduced in the right atrium (ra) and with a mapping system the ra, rv and cs were reconstructed.Subsequently, under electrogram and mapping system guidance there was no evidence of atrial activity across the cvti.The procedure outcome is unknown.No patent complication was reported.It is unknown if device will be returned.

• Brand Name: EP-XT STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20368639
• Report Number: 2124215-2024-62099
• Device Sequence Number: 3714319
• Product Code: DRF
• UDI-Device Identifier: 08714729877592
• UDI-Public: 08714729877592
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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 Model Number: 86718
• Device Catalogue Number: 86718
• Device Lot Number: 0033927033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown