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

Model Number 8668

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that the imaging catheter shaft damage occurred.The target lesion was located in the heart.A 6f guidezilla ii catheter-guide extension and an opticross imaging catheter were selected for use.During the procedure, the cutting balloon could not cross and the ultrasound catheter was advanced with difficulty due to a bulge in the guidezilla hypotube and the welding point.Upon withdrawal, the guidezilla cut the opticross imaging catheter, the physician withdrew the whole system.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The imaging window was observed detached near the lap joint section, it's important to mention that the imaging window was not returned for analysis.The telescope assembly was observed kinked.Microscopic inspection noted pitting and degradation of the transducer housing consistent with saline damage.Functional test could not be performed due to the condition in which the device returned.

Event Description

It was reported that the imaging catheter shaft damage occurred.The target lesion was located in the heart.A 6f guidezilla ii catheter-guide extension and an opticross imaging catheter were selected for use.During the procedure, the cutting balloon could not cross and the ultrasound catheter was advanced with difficulty due to a bulge in the guidezilla hypotube and the welding point.Upon withdrawal, the guidezilla cut the opticross imaging catheter, the physician withdrew the whole system.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.

• Brand Name: OPTICROSS HD
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15338205
• MDR Text Key: 303411210
• Report Number: 2124215-2022-33273
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: 08714729960768
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173284
• 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,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2023
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0029459672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: No
• 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: Male
• Patient Weight: 74 KG