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

Model Number 8655

Device Problems Unable to Obtain Readings (1516); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.In order to inspect for imaging core (ic) windup at the proximal end of the catheter, the hub rotator retainer clip was removed.The rotator and imaging core assembly was pulled out from hub.No ic windup was found within the telescope section and the sheath section of the device.The imaging window was detached from the lapjoint section of the device.No other visual damages were encountered upon visual inspection.Impedance testing shows an electrical open at proximal wave form.During image characterization testing, no image appeared in the ilab system.The distal housing of the transducer was observed complete and with no shattered pieces before the flushing process.No other issues or defects were observed during product analysis of the returned device.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray analysis the electrical issue was the result of a broken coax cable.

Event Description

Reportable based on device analysis completed on 14aug2020.It was reported that the tip of the catheter was damaged and could not show the image.The patient presented with trigeminal lesions in the left main artery.During the procedure involving an opticross imaging catheter, it was noted that tip of the catheter was damaged and could not show the image.The device was removed and the procedure completed with a different device.The patient status was stable.However, device analysis revealed an imaging window detachment from the lapjoint section.

• 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: 10505019
• MDR Text Key: 206101976
• Report Number: 2134265-2020-12496
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0024769883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2019
• 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
• Patient Weight: 65