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

Model Number 8655

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  Injury  

Event Description

It was reported that stuck in stent occurred.The 75% stenosed 20mm in length, 3.0mm in diameter target lesion was located in the mildly tortuous and moderately calcified left anterior descending (lad) artery.An opticross imaging catheter was selected for use.A 2.5mm non bsc stent was previously placed in mid lad and there was circumferential calcification at the proximal part of the stent.After performing pre-dilatation,a 3.00 x 20mm synergy stent was deployed from the proximal lad and was slightly overlapping the proximal part of the previously placed mid lad stent.No stent malapposition was noted with the placed stent.During dilatation, the struts at the mid to distal portion of the stent were pushed and overlapping area of stents, which have difference in internal diameter, became thicker.Then post-dilatation was performed with a 3.5mm balloon catheter from the proximal side and after the last checking of the stent placement area, the ivus catheter got caught in the lesion, and it got stuck in a 3.00x20mm synergy stent.It was rotated more, then tried to remove, but it could not be removed.Guidewire which was inserted in cx was inserted in lad main and the device was removed successfully.Final checking was performed and the procedure was completed with another of the same device.No patient complications were reported and the patient status is good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.There was no damage observed on the distal tip or guidewire exit port assembly.No other visual damages or detachment section were encountered upon visual inspection.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.No other issues or defects were observed during product analysis of the returned device.

Event Description

It was reported that stuck in stent occurred.The 75% stenosed 20mm in length, 3.0mm in diameter target lesion was located in the mildly tortouus and moderately calcified left anterior descending (lad) artery.An opticross imaging catheter was selected for use.A 2.5mm non bsc stent was previously placed in mid lad and there was circumferential calcification at the proximal part of the stent.After performing pre-dilatation,a 3.00 x 20mm synergy stent was deployed from the proximal lad and was slightly overlapping the proximal part of the previously placed mid lad stent.No stent malapposition was noted with the placed stent.During dilatation, the struts at the mid to distal portion of the stent were pushed and overlapping area of stents, which have difference in internal diameter, became thicker.Then post-dilatation was performed with a 3.5mm balloon catheter from the proximal side and after the last checking of the stent placement area, the ivus catheter got caught in the lesion, and it got stuck in a 3.00x20mm synergy stent.It was rotated more, then tried to remove, but it could not be removed.Guidewire which was inserted in cx was inserted in lad main and the device was removed succesfully.Final checking was performed and the procedure was completed with another of the same device.No patient complications were reported and the patient status is good.

• Brand Name: OPTICROSS
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8700701
• MDR Text Key: 148050891
• Report Number: 2134265-2019-06962
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0023520806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 45