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

Model Number	86705
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10167721
• Report Number: 2134265-2020-08200
• Device Sequence Number: 2115675
• Product Code: DRF
• UDI-Device Identifier: 08714729879923
• UDI-Public: 08714729879923
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1