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

Model Number 8655

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the imagine widow was detached.Microscopic inspection revealed pitting and degradation of the transducer housing consistent with saline damage which occurs post-use of the device and is not related to the original device failure.Impedance testing showed an electrical open at the proximal wave form.The device was sent for x-ray analysis and based on the x-ray images, a windup was noted inside the hub assembly and a broken drive shaft was observed at the distal end of the connector shaft.

Event Description

Reportable based on device analysis completed on 17may2022.It was reported that visualization issues occurred.The opticross imaging catheter was selected for ultrasound examination of the target lesion.Before the catheter was introduced, it was tested outside the patient, but there was no image even after the device was flushed several times.The procedure was completed with another of the same device.There were no patient complications and the patient condition was good.However, device analysis revealed imaging window detachment.

• 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: 14602794
• MDR Text Key: 293360126
• Report Number: 2134265-2022-06425
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0028490948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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: 65 YR
• Patient Sex: Female