MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC ANGIOJET; CATHETER, CONTINUOUS, FLUSH

Lot Number 22628363

Device Problems Leak/Splash (1354); Failure to Prime (1492)

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

Event Date 04/11/2019

Event Type  malfunction  

Event Description

Angiojet was connected to the machine, device started to leak and would not prime.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC ANGIOJET
• Type of Device: CATHETER, CONTINUOUS, FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8528296
• MDR Text Key: 142544374
• Report Number: MW5085982
• 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: 04/15/2019

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 Lot Number: 22628363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2019
• 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: 78 YR