MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 7760

Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that foreign material was present in the device.An expo guide catheter was selected for use.During the procedure, when the catheter was being flushed prior to insertion into the patient, a piece of plastic came out on the wire before entering into the patient.The procedure was completed with a different device.No patient complications reported.

Manufacturer Narrative

B3: date of event: date of event was approximated to (b)(6) 2024 as no event date was reported.

Event Description

It was reported via medwatch mw5150064 that foreign material was present in the device.An expo guide catheter was selected for use.During the procedure, when the catheter was being flushed prior to insertion into the patient, a piece of plastic came out on the wire before entering into the patient.The procedure was completed with a different device.No patient complications reported.It was further reported that the catheter was not allowing the wire to pass through.

Manufacturer Narrative

B3 - date of event updated from 01/01/2024 to (b)(6) 2024.Media provided from the facility was reviewed.Although media depicted a photo of white foreign matter and there is visibility of a device tip and unknown location on the shaft, the media was deemed as inconclusive as no device was returned to bsc to confirm the difficulty to track over wire and origin of the white foreign matter.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18592240
• MDR Text Key: 334837967
• Report Number: 2124215-2024-01652
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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: 7760
• Device Catalogue Number: 7760
• Device Lot Number: 0060500299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1