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

Model Number 86705

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that a dynamic xt catheter was found to have filaments of "suspected origin" on the catheter.There was no procedure involved.

Event Description

It was reported that a dynamic xt catheter was found to have filaments of "suspected origin" on the catheter.There was no procedure involved.

Manufacturer Narrative

Visual inspection of the device and returned packaging showed the cardboard package and the protective tube showed kinked and wrinkling.Inside the pouch of the returned the device what seemed to be a hair was found in the middle of the pouch, consequently, it confirms the reported complaint.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.

• Brand Name: DYNAMIC XT
• 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: 10167721
• MDR Text Key: 195562635
• Report Number: 2134265-2020-08200
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729879923
• UDI-Public: 08714729879923
• Combination Product (y/n): N
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: 02/24/2022
• Device Model Number: 86705
• Device Catalogue Number: 86705
• Device Lot Number: 0023398851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1