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

Model Number 8655

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

The opticross ic catheter was returned for analysis.Visual inspection revealed a perforation at the distal section of the imaging window.Microscopic inspection revealed the distal housing of the transducer was detached from the imaging core.The guidewire exit port and tip were in good condition.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.

Event Description

Reportable based on device analysis completed on 07/20/2021.It was reported that retraction failure occurred.The target lesion was located in the tortuous proximal left circumflex artery.An opticross ic was introduced to visualize the target lesion.During the procedure, a retraction failure occurred within the device.The device was removed and the procedure completed with another of the same device.There were no complications reported and the patient status was stable.However, returned device analysis revealed an imaging window perforation.

• 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: 12308315
• MDR Text Key: 266047681
• Report Number: 2134265-2021-10296
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0026427933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 66