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

Model Number 86721

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 295900411
• Report Number: 2134265-2022-07903
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877950
• UDI-Public: 08714729877950
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K091370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male