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

Model Number 86718

Device Problems Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2019

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 during preparation of the ep-xt diagnostic catheter, it was noticed that there was a small pin hole in the sterile packaging.It was also noted that the bent/kinked.There were no patient involvement.

• Brand Name: EP XT
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9314935
• MDR Text Key: 173449028
• Report Number: 2134265-2019-13776
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877592
• UDI-Public: 08714729877592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

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: 86718
• Device Catalogue Number: 86718
• Device Lot Number: 0024115536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1