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

Model Number 8655

Device Problems Difficult to Flush (1251); Poor Quality Image (1408)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed a kink in the sheath assembly.Microscopic inspection revealed the transducer distal housing to be complete and with no shattered pieces.The vent hole was in good condition, however, foreign matter was noted.Impedance testing showed an electrical open at distal wave form.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.However, pitting and degradation of the transducer housing consistent with saline damage was noted.

Event Description

Reportable based on device analysis completed on 15oct2021.It was reported that visualization issues occurred.The 85% stenosed, 15 x 3.50mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The opticross ic imaging catheter was advanced for ultrasound examination of the target lesion.The image was too dark and the device could not be primed normally.The device was removed and the procedure completed with another of the same device.There were no patient complications reported and the patient status was stable.However, device analysis revealed foreign matter.

• 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: 12667909
• MDR Text Key: 277656316
• Report Number: 2134265-2021-13230
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0027134243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 66