MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI

Model Number 08714729889663

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  Injury  

Event Description

While using angiojet, device became adhered to the wire.Could not remove device so everything including wire had to be pulled out, so aspiration portion of procedure was unable to be completed.The wire used for the procedure was on 0.035 glidewire.The angiojet was inspected after removal from pt, and it appeared to have small holes or tears in the catheter inhibited it from being flushed and aspirated correctly.No portion of device was in the pt confirmed with.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: ANGIOJET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; maple grove MN
• MDR Report Key: 8038039
• MDR Text Key: 126248429
• Report Number: MW5081042
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2020
• Device Model Number: 08714729889663
• Device Catalogue Number: 109681-001
• Device Lot Number: 22147996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 98