MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800350
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with may-thurner syndrome for a venogram procedure.Vascular access was obtained via bilateral femoral vein approach with unknown 8f sheaths.The 79% stenosed target lesion was located in the moderately calcified vessel compressing the left iliac vein.After an amplatz super stiff guidewire was inserted, an opticross 35 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, after the catheter imaged the target lesion with no issues, the catheter was placed back on the right side to re-image for stent landmark.However, upon trying to remove the catheter, it became stuck on the wire.Re-flushing did not resolve the issue.The opticross catheter and amplatz wire were then removed together.The wire split the catheter lumen when attempted to remove outside the patient's body.The procedure was completed with another of the same opticross catheter and amplatz wire.No patient complications were reported.
Additional Manufacturer Narrative
D2b pro code: obj, itx.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the device was received with a guide wire stuck, and the sheath assembly section was torn.D2b pro code: obj, itx.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with may-thurner syndrome for a venogram procedure.Vascular access was obtained via bilateral femoral vein approach with unknown 8f sheaths.The 79% stenosed target lesion was located in the moderately calcified vessel compressing the left iliac vein.After an amplatz super stiff guidewire was inserted, an opticross 35 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, after the catheter imaged the target lesion with no issues, the catheter was placed back on the right side to re-image for stent landmark.However, upon trying to remove the catheter, it became stuck on the wire.Re-flushing did not resolve the issue.The opticross catheter and amplatz wire were then removed together.The wire split the catheter lumen when attempted to remove outside the patient's body.The procedure was completed with another of the same opticross catheter and amplatz wire.No patient complications were reported.

• Brand Name: OPTICROSS 35
• 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: 17504113
• Report Number: 2124215-2023-41467
• Device Sequence Number: 12360376
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• 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): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2025
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0031913296
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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
• Patient Sex: Unknown