MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 8655

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that foreign material was observed.An opticross imaging catheter was selected for use.After flushing was performed, the wire lumen could not be passed through, however when it was checked, an object like a piece of plastic was stuck.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that no issues or abnormalities were found, the device appears to be in good conditions.It was received a little piece of plastic as evidence.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.No other issues or defects were observed during product analysis of the returned device.

Event Description

It was reported that foreign material was observed.An opticross imaging catheter was selected for use.After flushing was performed, the wire lumen could not be passed through, however when it was checked, an object like a piece of plastic was stuck.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: OPTICROSS
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8888155
• MDR Text Key: 154139195
• Report Number: 2134265-2019-09650
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0023864787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1