MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 16599302

Device Problems Physical Resistance (2578); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

Event Type  malfunction  

Event Description

Jl4 cath had tube of plastic within it.Plastic was pushed out by wire outside of body.Noticing the wire was not advancing through the catheter, patient safety report stated: while advancing a wire through a catheter, i noticed resistance and immediately told doctor.Catheter was removed and investigated as to why, it revealed a 5-6 cm piece of plastic within catheter.New catheter was dropped and case finished without incident or harm to patient.Contacted boston scientific on the day of the event, they are sending me shipping material.I asked if they knew what this could be? i asked if they felt i should pull the other devices with the same lot numbers and they said they could not advise until they investigate.I will be sending a pic.

• Brand Name: IMPULSE ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave. n; saint paul MN 55112
• MDR Report Key: 6497479
• MDR Text Key: 72917378
• Report Number: 6497479
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 16599302
• Device Lot Number: 60039687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 78