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 Patient Involvement (2645)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The product analysis was performed.A detachment was observed in the female tubing of the telescope assembly.Impedance testing shows an electrical open at distal wave form.Image testing could not be performed due to the observed detachment.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray analysis, no discernible defect could be seen.

Event Description

Reportable based on device analysis completed on 28may2020.It was reported that catheter could not show image occurred.The target lesion was located in the coronary artery.An opticross ic was advanced for use.But during preparation, the catheter could not show the image.The procedure was completed with another of the same device.There were no patient involvement reported and the patient's status was stable.However, returned device analysis revealed a catheter electrical failure and telescope detached/separated.

• 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: 10197163
• MDR Text Key: 196489966
• Report Number: 2134265-2020-08578
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: 08714729890393
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0024546847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2019
• 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: 44 YR
• Patient Weight: 65