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 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6).

Event Description

It was reported that the tip was contaminated.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.An opticross catheter was selected for use.During device check, flushing was performed, however the tip was noted to be contaminated.The procedure was completed with another of the same device.No patient complications were reported and patient condition is good.

Manufacturer Narrative

Age at time of event: 72 years device evaluated by mfr: analysis of returned product revealed that the catheter was visually inspected and did not show any damage or abnormality at the distal tip or along the imaging window that could contribute to the complaint.No other visual damages were encountered upon visual inspection.

Event Description

It was reported that the tip was contaminated.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.An opticross catheter was selected for use.During device check, flushing was performed, however the tip was noted to be contaminated.The procedure was completed with another of the same device.No patient complications were reported and patient condition is good.

• 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: 8861999
• MDR Text Key: 153437521
• Report Number: 2134265-2019-09097
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: 08714729890393
• Combination Product (y/n): N
• PMA/PMN Number: K161125
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2019
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0022443684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1