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

Model Number	86709
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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 the tip of catheter was apart from shaft.Before the procedure a dynamic xt electrode catheter was selected for use.It was found that the tip of catheter was apart from shaft.The procedure was completed with this device without any patient complications.
Event or Problem Description
It was reported that the tip of catheter was apart from shaft.Before the procedure a dynamic xt electrode catheter was selected for use.It was found that the tip of catheter was apart from shaft.The procedure was completed with this device without any patient complications.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.The returned device was analyzed and visual inspection revealed the tip was detached from the edge of the shaft.Dissection of the catheter revealed the detachment was due to the lack of epoxy, the unit was compared against control units and it matches with the unit without epoxy in the distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 10326134
• Report Number: 2134265-2020-09958
• Device Sequence Number: 19635684
• Product Code: DRF
• UDI-Device Identifier: 08714729877639
• UDI-Public: 08714729877639
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 09/04/2022
• Device Model Number: 86709
• Device Catalogue Number: 86709
• Device Lot Number: 0024381703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1