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

Model Number	8655
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection shows the imaging window was partially detached from the lapjoint section.The distal housing of the transducer was near the tip of the device when the telescope was fully advanced.It was observed that the catheter did not flushed normally due to the partial detachment of the imaging window.Impedance testing shows an electrical open at distal wave form.Image characterization testing could not be performed due to the observed partial detachment.No other issues or defects were observed during product analysis of the returned device.
Event or Problem Description
Reportable based on device analysis completed on 20may2020.It was reported that lost image occurred.An opticross imaging catheter was selected for use.During procedure, the physician prepped and tested outside the body and it was working.They went into the body and it was still working.They gave another flush and when they went to record the image was gone and it no longer worked.The procedure was completed with different of same device.No patient complications were reported.However, device analysis noted the imaging window was partially detached from the lapjoint section.

• Brand Name: OPTICROSS
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10148571
• Report Number: 2134265-2020-07949
• Device Sequence Number: 11306914
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0024437466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1