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

Model Number	86709
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2019
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 contaminants were found inside the sterile packaging.Following inspection of a dynamic xt catheter prior to use in a procedure, presence of "filaments of suspected origin" were observed." foreign material was found inside the sterile seal.No patient was involved.
Additional Manufacturer Narrative
The device was returned for analysis.The catheter was returned with its original box; however, the pouch was found sealed.Within the sealed pouch of the device was observed a fiber of foreign matter.This foreign matter moved freely within the sealed pouch.Dimensional test failed since it was confirmed that the foreign matter within the sealed pouch was smaller than the 1.00 square millimeters comparation line of the tappi chart.
Event or Problem Description
It was reported that contaminants were found inside the sterile packaging.Following inspection of a dynamic xt catheter prior to use in a procedure, presence of "filaments of suspected origin" were observed." foreign material was found inside the sterile seal.No patient was involved.

• 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: 9256380
• Report Number: 2134265-2019-13187
• Device Sequence Number: 11677583
• Product Code: DRF
• UDI-Device Identifier: 08714729877639
• UDI-Public: 08714729877639
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: Other
• Device Expiration Date: 04/25/2021
• Device Model Number: 86709
• Device Catalogue Number: 86709
• Device Lot Number: 0022045973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1