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

Model Number 8655

Device Problems Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2018

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 03-dec-2018.It was reported that missing image occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.During procedure, an opticross imaging catheter was selected for use, however, no image appeared even after several reconnection attempts.The procedure was completed with a non bsc device.No patient complications were reported.However, returned device analysis revealed that the sheath and the imaging window of the returned unit are separated at the lap joint.Device evaluated by mfr: investigation completed.Device was returned for analysis.The unit returned has a kink in the sheath and the imaging window of the returned unit is separated at the lap joint.The separated imaging window was not returned.A kink was observed in the sheath assembly from femoral marker to the proximal end, additionally a damaged was observed in the lap joint area of the catheter.Impedance testing shows a good unit wave form.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8165485
• MDR Text Key: 130387994
• Report Number: 2134265-2018-64313
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0022433029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1