MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. ANGIOJET SOLENT OMNI OVER THE WIRE THROMBECTOMY SET; CATHETER, CORONARY, ATHERECTOMY

Model Number CE0086

Device Problems Failure to Prime (1492); Defective Device (2588)

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

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Patient underwent aorto-iliac-femoral arteriogram, catheter directed thrombectomy right aorto-iliac and iliac-femoral, angioplasty and stent placement right aorto-iliac and common iliac-external iliac with dr (b)(6).The angiojet thrombectomy set was defective.The device would not prime.Fda safety report id # (b)(4).

• Brand Name: ANGIOJET SOLENT OMNI OVER THE WIRE THROMBECTOMY SET
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 9910067
• MDR Text Key: 186137783
• Report Number: MW5093990
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: CE0086
• Device Lot Number: 25101211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2020
• 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: 82 YR
• Patient Weight: 76