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

Model Number 8669

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.The bifurcated target lesion was located in the ramus and circumflex.An opticross 6 hd catheter was advanced over a non-boston scientific wire for intravascular ultrasound (ivus) examination of the target lesion.During the last run, the proximal portion of the stent was not visualized because the guide was seated too deeply.The catheter was advanced again and imaging was turned on at the ostium of the left main and then turned off when the guide was backed out.At some point, the opticross catheter had grabbed onto the wire and the wire was stripped.The catheter was removed intact and the procedure was completed without post-ivus of the proximal portion of the stent.There were no patient complications.

Event Description

It was reported that device entrapment occurred.The bifurcated target lesion was located in the ramus and circumflex.An opticross 6 hd catheter was advanced over a non-boston scientific wire for intravascular ultrasound (ivus) examination of the target lesion.During the last run, the proximal portion of the stent was not visualized because the guide was seated too deeply.The catheter was advanced again and imaging was turned on at the ostium of the left main and then turned off when the guide was backed out.At some point, the opticross catheter had grabbed onto the wire and the wire was stripped.The catheter was removed intact and the procedure was completed without post-ivus of the proximal portion of the stent.There were no patient complications.It was further reported that a kink was observed in the sheath assembly, the guidewire exit port was found torn.And it was also noted pitting and degradation of the transducer housing consistent with saline damage.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed that a kink in the sheath assembly.The telescope assembly was able to properly pull back, advance, and retract.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.Microscopic inspection revealed the guidewire exit port was torn.

• Brand Name: OPTICROSS 6 HD
• Type of Device: 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: 16891534
• MDR Text Key: 314813739
• Report Number: 2124215-2023-22405
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: 08714729960775
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8669
• Device Catalogue Number: 8669
• Device Lot Number: 0031171329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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