MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC TIP¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0042001310

Device Problems Defective Device (2588); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

Boston scientific electrophysiology catheter, was proved defective by the medical doctor and item had to be replaced.The catheter was in the body when found defective, no harm to patient.The intracardiac signals on channels 1-2 were very noisy.The catheter was saved and given to materials management.

• Brand Name: DYNAMIC TIP¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8514225
• MDR Text Key: 141935470
• Report Number: 8514225
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2019

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 Model Number: M0042001310
• Device Catalogue Number: REF #M0042001310
• Device Lot Number: 22979323
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1