MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIA; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86721
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on (b)(6) 2022.During preparation, a radia catheter was selected for use.It was reported that the catheter was defective and did not work.A different catheter was used to complete the procedure.No patient complications were reported.During product analysis, it was observed the distal end detached from the catheter shaft.
Additional Manufacturer Narrative
The device was received at boston scientific for analysis.Visual inspection noted the distal end was detached from the catheter shaft.It is possible the distal end was dissected because the device was stuck and an excessive force applied could cause the damage, or bad manipulation during the preparation could cause the damage observed.

• Brand Name: RADIA
• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15016067
• Report Number: 2134265-2022-07903
• Device Sequence Number: 17828493
• Product Code: DRF
• UDI-Device Identifier: 08714729877950
• UDI-Public: 08714729877950
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2022

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: 05/14/2022
• Device Model Number: 86721
• Device Catalogue Number: 86721
• Device Lot Number: 0023799221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male