MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8655
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Chest Pain (1776); Reduced Blood Flow (4598)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.An opticross imaging catheter was selected for intravascular ultrasound (ivus) examination of the target lesion and the catheter and the sled were prepared appropriately.The catheter was inserted and when pullback was attempted, the catheter would not pullback.The motor drive unit was removed and reinserted into the sled, but pullback would not start.A new sled was opened and pre and post ivus for the lad were performed.The circumflex artery was also diseased and was wired.When the opticross catheter was inserted, the transducer would not advance out of the guide catheter.The patient started to have chest pain, so the catheter was removed, and an angiogram was taken.Air embolism was observed, and the lad had no blood flow.The patient was given vasodilators and within a few minutes the lad was open, and the patient recovered.The procedure was completed successfully without ivus.After the case, the catheter was inspected, and it was noted that a part near the hub was broken which stopped the sled from pulling back.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed kinks in the sheath and telescope with the telescope detached in the anchor housing section.
Event or Problem Description
It was reported that patient complications occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.An opticross imaging catheter was selected for intravascular ultrasound (ivus) examination of the target lesion and the catheter and the sled were prepared appropriately.The catheter was inserted and when pullback was attempted, the catheter would not pullback.The motor drive unit was removed and reinserted into the sled, but pullback would not start.A new sled was opened and pre and post ivus for the lad were performed.The circumflex artery was also diseased and was wired.When the opticross catheter was inserted, the transducer would not advance out of the guide catheter.The patient started to have chest pain, so the catheter was removed, and an angiogram was taken.Air embolism was observed, and the lad had no blood flow.The patient was given vasodilators and within a few minutes the lad was open, and the patient recovered.The procedure was completed successfully without ivus.After the case, the catheter was inspected, and it was noted that a part near the hub was broken which stopped the sled from pulling back.

• Brand Name: OPTICROSS 6
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18358579
• Report Number: 2124215-2023-72224
• Device Sequence Number: 7731073
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0032092143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown