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

Model Number 8655

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that the imaging window was detached from the lapjoint.A kink was observed in the proximal section of the sheath assembly.A kink was observed in the imaging core.The rotator and imaging core assembly were pulled out from the removed hub.Broken drive shaft and imaging core windup was found within the telescope section of the device.Windup were encountered in the double heat shrink area of the telescope.Imaging core windup began 18.90 cm from the distal end of the connector shaft.Impedance testing shows an electrical open at proximal wave form.The distal housing was observed complete with no shattered sections.No other issues or defects were observed during product analysis of the returned device.

Event Description

Reportable based on device analysis completed on 19may2020.It was reported that lost image occurred.The 75% stenosed lesion was located in the moderately tortuous and moderately calcified right coronary artery.An opticross imaging catheter was selected for use.During preparation it was noted that the image was not shown when image testing before a percutaneous coronary intervention.The procedure was completed with a different device.No patient complications were reported.However, device analysis noted the imaging window was detached from the lapjoint.

• Brand Name: OPTICROSS
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10145779
• MDR Text Key: 194873265
• Report Number: 2134265-2020-07910
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: 08714729890393
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K161125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0024920361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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
• Patient Age: 75 YR